FDA Adverse Event
Malfunction
Summary report: N
DIAMOND-EDGES PAR SCISSORS
MDR report key: 330621
·
Received May 4, 2001
Report
- Report Number
- 1038548-2001-00021
- Event Type
- Malfunction
- Date Received
- May 4, 2001
- Date of Event
- April 4, 2001
- Report Date
- April 5, 2001
- Manufacturer
- GENZYME SURGICAL PRODUCTS CORP.
- Product Code
- LRW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING SURGERY, THE TIPS BROKE AND FELL INTO THE PATIENT. IT TOOK A WHILE TO LOCATE AND REMOVE THE TIP HOWEVER, THE PATIENT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20568 | DIAMOND-EDGES PAR SCISSORS | SCISSORS | LRW | GENZYME SURGICAL PRODUCTS CORP. | NA | 446601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |