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 2016-06-14 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[47294162]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[47294163]
According to the report, "staff opened the sologrip and reported exposed wires. "
Patient Sequence No: 1, Text Type: D, B5
[54669550]
According to the report, "staff opened sologrip iii and reported exposed wires. " (b)(4). 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. A sample review was conducted on (b)(6) 2016. The returned handpiece was visually inspected. The hospital returned handpiece ta-04069-23 in the cryolife supplied sample return packaging. The white sheath was broken in small pieces in numerous locations. The random broken spots on the sheath were brittle and easily broken or "snapped" under minimal stress. A slight color variation was noted in the broken segments. No other damages were noted to the handpiece. The root cause remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[54669551]
According to the report, "staff opened the sologrip and reported exposed wires. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00056 |
| MDR Report Key | 5722489 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-14 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-05-18 |
| Date Mfgr Received | 2016-05-18 |
| Date Added to Maude | 2016-06-14 |
| 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 | 2016-06-14 |
| Returned To Mfg | 2016-06-06 |
| Model Number | HP-SG3 |
| Lot Number | TA-04069 |
| Device Expiration Date | 2017-02-26 |
| 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 | 2016-06-14 |