MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-11-17 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[31389148]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[31389149]
According to the report, the white cord on each of the handpieces are cracked and exposing the wire. This was noticed once these 2 products were opened and about to be used in a case. Additional information from the nurse during the case stated "the first one they took out went to used it once i think they said and then they discovered the crack and then as they were manipulating/inspecting it, it began to crack in more places. The second one they opened and inspected and looked good so they used it and during use they again discovered it had cracked also. Both of these are well within their expiration dates so there should be no issues there. "
Patient Sequence No: 1, Text Type: D, B5
[45772592]
According to the report, the white cord on each of the handpieces are cracked and exposing the wire. This was noticed once these 2 products were opened and about to be used in a case. Additional information from the nurse during the case stated "the first one they took out went to used it once i think they said and then they discovered the crack and then as they were manipulating/inspecting it began to crack in more places. The second one they opened and inspected and looked good so they used it and during use they again discovered it had cracked also. Both of these are well within their expiration dates so there should be no issues there. " the hospital returned handpieces ta-04069-(b)(4), ta-04069-(b)(4), and ta-04069-(b)(4). The handpieces were visually inspected. Handpieces serial numbers (b)(4) were opened and (b)(4) had been used. Handpiece serial number (b)(4) was unopened and was in the original packaging; it was sent back as it was in the same lot as handpieces (b)(4). It was determined that the handpieces would not be sent for decontamination to keep the integrity intact. The handpieces were visually inspected by subject matter experts from research & development. Handpiece (b)(4) was transected in numerous areas. All the broken areas were proximal to the handle. The white sheath was breaking off from the fiber in small pieces. Handpiece (b)(4) was noted to have discoloration all along the white sheath distal to the handle. It was transected in numerous locations all along the sheath. Both handpieces had random spots on the sheath that were brittle and easily breakable. A 1" dilator was used to see how flexible the sheath was and how easily it would break if wrapped around an object such as the dilator. The handpieces were connected to the hene (helium-neon) laser to test output. Both handpieces effectively delivered laser throughout the length of the handpieces with no breaks in the laser fiber. The thumb slide mechanisms on both handpieces were functional and the fibers retracted without problem. Handpiece (b)(4) was not inspected outside of the package. Discoloration was noted through the packaging. The unopened handpiece was returned to the contract manufacturer for further evaluation as part of a corrective/preventive action. The evaluation received from the quality control supervisor at the contract manufacturer stated the following: "i was able to evaluate this unit along with our manufacturing lead and one of our in-process inspectors. Visual inspection prior to opening pouch and tray: there was an obvious crack in the tubing (distal end). The tubing had an obvious discoloration (yellowing) and appeared more noticeable on the proximal end of the tubing. Inspection of unit: the tubing cracked in multiple places as i was spiraling around the cylinder. This condition was identical on both the distal and proximal end. Observation: the tubing felt hard (brittle) right out of the package. The tubing would actually crack with just a light touch without spiraling. I can't imagine that tubing in this condition could ever make it through manufacturing without being noticed. Specifically, the packaging process when it gets coiled into the tray. " the contract manufacturer contacted the tubing extruder, whose response was "the conclusion is that we have not seen anything like this in any of the products that we extrude in here. " the manufacturing records for lot ta-04069 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. The lot passed functional testing and met cryolife release specifications. No root cause could be identified.
Patient Sequence No: 1, Text Type: N, H10
[45772593]
According to the report, the white cord on each of the handpieces are cracked and exposing the wire. This was noticed once these 2 products were opened and about to be used in a case. Additional information from the nurse during the case stated "the first one they took out went to used it once i think they said and then they discovered the crack and then as they were manipulating/inspecting it began to crack in more places. The second one they opened and inspected and looked good so they used it and during use they again discovered it had cracked also. Both of these are well within their expiration dates so there should be no issues there. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00347 |
| MDR Report Key | 5229860 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-11-17 |
| Date of Report | 2016-05-23 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-10-30 |
| Date Added to Maude | 2015-11-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLOGRIP III HANDPIECE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE |
| Product Code | MNO |
| Date Received | 2015-11-17 |
| Returned To Mfg | 2015-11-06 |
| Model Number | HP-SG3 |
| Lot Number | TA-04069 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-17 |