FDA Adverse Event
Injury
Summary report: N
ARTHROSCOPIC GRASPER WITH RATCHET HANDLE
MDR report key: 39757
·
Received September 25, 1996
Report
- Report Number
- 1418479-1996-00011
- Event Type
- Injury
- Date Received
- September 25, 1996
- Date of Event
- August 14, 1996
- Report Date
- August 27, 1996
- Manufacturer
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- Product Code
- HRX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN ARTHROSCOPY OF THE KNEE, A PIECE OF MENISCUS WAS BEING REMOVED WHEN THE LOWER JAW OF THE ARTHROSCOPIC GRASPER BROKE OFF INTO THE SURGICAL SITE. ADD'L SURGERY WAS DONE TO REMOVED THE FOREIGN BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHROSCOPIC GRASPER WITH RATCHET HANDLE | ARTHROCOPIC GRASPER | HRX | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 8403.985 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 * | Required Intervention |