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 2016-01-22 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[36708600]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
[36708601]
According to the initial report, "the fiber of the handpiece broke while in use. " additional information is pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00007 |
| MDR Report Key | 5386278 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-01-22 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-10-22 |
| Date Added to Maude | 2016-01-22 |
| 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 | 2016-01-22 |
| Model Number | HP-SG3 |
| Lot Number | TA-04081 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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 | 2016-01-22 |