FDA Adverse Event
Injury
Summary report: N
STORTZ
MDR report key: 273128
·
Received April 3, 2000
Report
- Report Number
- MW1018619
- Event Type
- Injury
- Date Received
- April 3, 2000
- Date of Event
- March 22, 2000
- Report Date
- March 29, 2000
- Manufacturer
- BAUSCH & LOMB SURGICAL, INC.
- Product Code
- KBZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- RI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING TONSILLECTOMY SURGERY, TONSIL SNARE MALFUNCTIONED WHILE DR WAS REMOVING THE TONSIL - TONSIL SNARE WOULD NOT CUT COMPLETELY THROUGH THE TONSIL. DR HAD TO USE SCISSORS TO REMOVE TONSIL. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORTZ | TONSIL SNARE | KBZ | BAUSCH & LOMB SURGICAL, INC. | N6377 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |