FDA Adverse Event
Other
Summary report: N
RENEW HANDPIECE, 34CM REUSABLE
MDR report key: 4184039
·
Received October 15, 2014
Report
- Report Number
- 1223422-2014-00035
- Event Type
- Other
- Date Received
- October 15, 2014
- Report Date
- October 14, 2014
- Manufacturer
- MICROLINE SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K962119
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS: THE DEVICE WAS RETURNED AND INVESTIGATED. THE CUSTOMER COMPLAINT STATED THAT DURING A SURGICAL PROCEDURE, AN ELECTRICAL ARC OCCURRED RESULTING IN A BURN TO THE PT. VISUAL AND MECHANICAL EXAMINATION OF THE DEVICE REVEALED THAT THE DEVICE HAD BEEN RE-MANUFACTURED. SUMMARY/CONCLUSION: THE DEVICE HAS BEEN TAMPERED WITH AND RE-MANUFACTURED. DUE TO THE RE-MFG OF THE DEVICE, MSI PRODUCT DID NOT CAUSE THIS ADVERSE EVENT.
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE, AN ELECTRICAL ARC OCCURRED RESULTING IN THE PT BEING BURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652828 | RENEW HANDPIECE, 34CM REUSABLE | MANUAL DETACHABLE SURGICAL INSTRUMENTS | GEI | MICROLINE SURGICAL, INC. | 3904 | 47259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |