FDA Adverse Event
Injury
Summary report: N
LIFE INSTRUMENT CO. 4MM KERRISON RONGEUR
MDR report key: 20855029
·
Received December 4, 2024
Report
- Report Number
- MW5163225
- Event Type
- Injury
- Date Received
- December 4, 2024
- Date of Event
- November 26, 2024
- Report Date
- November 29, 2024
- Manufacturer
- LIFE INSTRUMENT CORP
- Product Code
- HAO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
KERRISON BROKE DURING SURGERY, BOTH PIECES RETRIEVED, NO HARM TO PATIENT, INSTRUMENT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2290683 | LIFE INSTRUMENT CO. 4MM KERRISON RONGEUR | INSTRUMENT, SURGICAL, NON-POWERED | HAO | LIFE INSTRUMENT CORP | 830-08040-0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |