FDA Adverse Event
Malfunction
Summary report: N
MICROSUTURE SCISSORS
MDR report key: 28089
·
Received November 16, 1995
Report
- Report Number
- MW1007677
- Event Type
- Malfunction
- Date Received
- November 16, 1995
- Date of Event
- November 3, 1995
- Report Date
- November 8, 1995
- Manufacturer
- ACCURATE SURGICAL AND SCIENTIFIC INSTRUMENT CORP.
- Product Code
- LRW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TIP OF MICROSUTURE SCISSORS WAS NOTED TO BE BROKEN OFF AT THE END OF ABDOMINAL SURGERY. SILCO TIP APPROX 1 MM. AN X-RAY WAS NOT DONE AND THE SMALL BROKEN TIP WAS NOT FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSUTURE SCISSORS | MICROSUTURE SCISSORS | LRW | ACCURATE SURGICAL AND SCIENTIFIC INSTRUMENT CORP. | SA5-15T | SA5-15T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |