FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM CURVED METZENBAUM SCISSORS (LONG JAWS)
MDR report key: 1150092
·
Received August 29, 2008
Report
- Report Number
- 2936485-2008-00071
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 11, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- LRW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED, BY THE SALES REPRESENTATIVE, THAT ALLEGEDLY THE LAP SCISSORS WERE BENDING THE TISSUE AS THEY REPORTEDLY WERE CUTTING. THE DOCTOR WAS TRYING TO OPEN UP THE CYSTIC DUCT TO SHOOT A CHOLANGIOGRAM. THEY REPORTED THAT THE DISTAL TIP OF THE SCISSORS WERE NOT CUTTING. IT OCCURRED INTERMITTENTLY FOR THE FIRST INSTRUMENT. A SECOND INSTRUMENT WAS AVAILABLE, BUT IT WAS NOT CUTTING EITHER. IT WAS REPORTED THAT THE CHOLANGIOGRAM COULD NOT BE PERFORMED BECAUSE THEY COULD NOT GET THE DUCTS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM, 33CM CURVED METZENBAUM SCISSORS (LONG JAWS) | SCISSORS | LRW | STRYKER ENDOSCOPY SAN JOSE | 0744971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |