D
Patient 1
THE DEVICE (PART#: MCO23) WAS RETURNED TO MXI SERVICE AND REPAIR.
MAUDE MDR 3337549
- MDR report key
- 3337549
- Report number
- 9680837-2013-00105
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-06-24
- Date received
- 2013-08-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JONATHAN SCHLECH
- Address
- 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
- Phone
- 904-904-9043
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FORCEPS MC023 ALLIG 7MM JAWS STR | MEDTORNIC XOMED INSTRUMENTATION S.A.S. | KAE | MCO23 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-29 | 0 |
Event Narratives#
N
Patient 1
(B)(4). EVALUATION OF THIS INSTRUMENT INDICATED THAT THE WIRE WAS BROKEN. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. (B)(4).