FDA Adverse Event
Summary report: N
SLIMLINE SEMI-RIGID ALLIGATOR FORCEPS
MDR report key: 822188
·
Received November 2, 2004
Report
- Report Number
- 1519132-2004-00073
- Date Received
- November 2, 2004
- Date of Event
- October 19, 2004
- Manufacturer
- ACMI NORWALK
- Product Code
- HIH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
ACMI CONFIRMS THE STATIONARY JAW HAS SNAPPED. INSTRUMENT IS OVER 4 YEARS OLD. ACMI 100% TESTS ALL GYA-5 TO 15 LBS OF FORCE. THIS INSTRUMENT WAS SUBJECTED TO FORCES BEYOND DESIGN LIMITATIONS TO CAUSE FAILURE. THE INSTRUMENT SHOWS SIGNS OF HEAVY USAGE, (ETCHING, IS WORN, SCRATCHES, BENDS IN SHAFT.) THE FAILURE WAS LIKELY CAUSE TO IMPROPER CARE/MISHANDLING BY USER.
Description of Event or Problem · 1
ONE OF THE JAWS BROKE OFF AND HAD TO RETRIEVE ITEM FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIMLINE SEMI-RIGID ALLIGATOR FORCEPS | * | HIH | ACMI NORWALK | GYA-5 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |