FDA Adverse Event
Malfunction
Summary report: N
ACUFEX
MDR report key: 41185
·
Received September 13, 1996
Report
- Report Number
- 1219602-1996-00007
- Event Type
- Malfunction
- Date Received
- September 13, 1996
- Report Date
- August 21, 1996
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY, INC.
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TIP OF DEVICE WAS REPORTED TO HAVE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUFEX | SCREW DRIVER | HXX | SMITH & NEPHEW ENDOSCOPY, INC. | NA | 494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |