MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-05-20 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[45596867]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[45596868]
According to the report, "hp [handpiece] was fired and it would not work. So staff opened another hp and completed the case. "
Patient Sequence No: 1, Text Type: D, B5
[47823756]
According to the report, "hp [handpiece] was fired and it would not work. So staff opened another hp and completed the case. " additional information was requested via email on 04/06/2016. A reply was received on 04/06/2016 stating, "the handpiece tested fine. When he went to do the tmr, it did not fire. The second handpiece was readily available. " a sample review was conducted on 04/21/2016. The returned handpiece was visually inspected. The hospital returned handpiece (b)(4); however, the original packaging was not returned. The report stated that the handpiece test fired without an issue but when the surgeon attempted to use it, it would not fire. Upon removing it from the bag, (b)(4) had the multifilament fiber pulled out from the distal end of the coupler. The ends of the multifilament fiber appeared to be charred. The coupler was then opened and it also appeared charred inside. The inside of the coupler had pieces of broken and charred fibers inside of it. It appears as though the multifilament fiber end became dislodged and the handpiece was fired before the multifilament fiber end came completely out of the coupler. The root cause remains unknown; however the issue noted was most likely caused from some kind of mechanical force dislodging the multifilament fibers from the coupler and then attempting to fire it. The manufacturing records for lot ta-04089 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. The ifu states, "each sologrip iii handpiece is a fragile surgical instrument. Use caution when removing contents from packaging and during use. Excessive stress or tension on the optical fiber contained in the handpiece may result in device damage or malfunction. Always place the laser console near the sterile field. Position the white fiber coupler near the operative site to minimize tension on the fiber when the handpiece is in use. "
Patient Sequence No: 1, Text Type: N, H10
[47823757]
According to the report, "hp [handpiece] was fired and it would not work. So staff opened another hp and completed the case. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00048 |
| MDR Report Key | 5669580 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-20 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-05-20 |
| 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 | 2016-05-20 |
| Returned To Mfg | 2016-04-21 |
| Model Number | HP-SG3 |
| Lot Number | TA-04089 |
| Device Expiration Date | 2017-11-25 |
| 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 | 2016-05-20 |