FDA Adverse Event
Malfunction
Summary report: N
23G HOFFMAN/AHMED MICROSCISSORS STRAIGHT SHAFT
MDR report key: 2241532
·
Received August 10, 2011
Report
- Report Number
- 3019924-2011-00020
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 11, 2011
- Report Date
- August 10, 2011
- Manufacturer
- MICROSURGICAL TECHNOLOGY, INC.
- Product Code
- HNF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SCISSOR HAD DAMAGE THAT IS INDICATIVE OF MISHANDLING AND POOR MAINTENANCE.
Description of Event or Problem · 1
THE SURGEON REPORTED THAT THE SCISSOR BROKE WHILE CUTTING THE CAPSULAR BAG. THERE WAS NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 23G HOFFMAN/AHMED MICROSCISSORS STRAIGHT SHAFT | OPHTHALMIC SCISSORS | HNF | MICROSURGICAL TECHNOLOGY, INC. | DFH-0010 | 019591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |