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 2018-04-24 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[107089898]
A sample evaluation was performed for the returned handpiece, lot number ta-04108, serial (b)(4). The thumb slide was stuck at the most forward position (maximum optical fiber travel), with excessive force, the thumb slide finally moved back accompanies by an audible click. Once the thumb slide was freely moving, it was noticed that the polypropylene sheath covering the optical fiber bundle was damaged (cracked and starting to peel away) at the end of the optical fiber. It is possible there was an excessive amount of adhesive in the handle that caused the thumb slide to adhere to the handle. The plastic parts that make up the handle are assembled using adhesive during manufacturing. This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[107089899]
Per the initial report, "[complainant] called to let me know that [surgeon] had two (2) sologrip iii handpieces that where not functioning properly. He was not in the case, but texted me the number of [nurse] whom was scrubbed into [surgeon]'s case. This surgical team is very experienced with the cardiogenesis tmr laser procedure and products. I call [nurse] to discuss the case. She said they opened the first sologrip iii and she said that "the device did not look normal and the "cable was not connected to the "bubble" of the device. " they immediately opened a second sologrip iii handpiece, but [surgeon] and [nurse] tried, but could not make the laser channel mechanism to retract. A third sologrip iii was opened and worked as it should and was used in the case with normal standards and results. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00012 |
| MDR Report Key | 7456571 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-24 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-03-26 |
| Date Facility Aware | 2018-03-26 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-04-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2018-04-24 |
| Returned To Mfg | 2018-04-06 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04108 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-24 |