MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-02 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[76628168]
A review of the outside of the handpiece was performed. Visible burn marks were observed at the proximal end of the sheath (white portion of the handpiece). It was also noted that a white ring could be seen within the burn marks suggesting a break and/or bend at that point. The handpiece was attached to the laser for testing. The laser light did not travel to the end of the sheath. The sheath was removed from the heat shrink (black portion) and noticeable burn marks at the end of the sheath were observed. The laser light could be viewed at the end of the knurled nut but due to damage to the sheath, the light did not travel further. The heat sheath was opened so the inside could be viewed. Based on all observed damage to the handpiece it was suggested that the cause of the burning was due to a bend or break in the sheath over the single fiber. A definitive root cause is unknown and the investigation is currently ongoing. This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[76628169]
Initial reports for the event stated that the handpiece was tested and fired once with no problems. The device was then fired a second time and a "pop" was heard. A burning smell was noticed and a charred area was visible (exact location not specified). The resultant delay in the procedure did not cause adverse impact to the patient. The patient was discharged home after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00019 |
| MDR Report Key | 6608050 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-02 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-04-28 |
| Date Facility Aware | 2017-05-04 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-06-02 |
| 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 |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD |
| 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 |
| Product Code | MNO |
| Date Received | 2017-06-02 |
| Returned To Mfg | 2017-05-09 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04097 |
| Device Expiration Date | 2018-07-28 |
| 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 | 2017-06-02 |