FDA Adverse Event
Malfunction
Summary report: N
YOUNG PROSTATIC TRACTOR, SHORT
MDR report key: 228094
·
Received June 17, 1999
Report
- Report Number
- 1423507-1999-00166
- Event Type
- Malfunction
- Date Received
- June 17, 1999
- Date of Event
- June 10, 1999
- Report Date
- June 16, 1999
- Manufacturer
- ALLEGIANCE HEALTHCARE CORP.
- Product Code
- FFO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LOCK NUT SHEARED OFF RETRACTOR WHILE BLADES WERE IN OPEN POSITION DURING SURGICAL PROSTATE PROCEDURE. INSTRUMENT RETAINED AT HOSP FOR POSSIBLE LEGAL ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | YOUNG PROSTATIC TRACTOR, SHORT | INSTRUMENT | FFO | ALLEGIANCE HEALTHCARE CORP. | GU8386 | P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |