N
Patient 1
(B)(4). INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 8306579
- MDR report key
- 8306579
- Report number
- 9610612-2019-00053
- Event key
- 0
- Event type
- 3
- Date received
- 2019-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TC BABY-METZ SCISSORSDELCVDB/B145MM | BASIC INSTRUMENTS | AESCULAP AG | LRW | BC259R | BC259R | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-05 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN INTRAOPERATIVE ISSUE WITH THE SCISSORS DURING A PROCEDURE FOR CARPAL TUNNEL SYNDROME. IT BROKE SUDDENLY DURING NORMAL USE AND WITHOUT UNUSUAL CIRCUMSTANCES OR FORCE. THE TISSUE WAS BEING SPREAD USING THE BABY METZ SCISSORS WHEN THE MALFUNCTION OCCURRED; ONE OF THE SIDES OF THE HANDLE BROKE OFF NEAR THE JOINT. THE SURGICAL OUTCOME AND PATIENT DATA WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.