FDA Adverse Event
Malfunction
Summary report: N
24FR 30 CUTTING LOOP ELECTRODE, .014 (6BX)
MDR report key: 1982400
·
Received January 14, 2011
Report
- Report Number
- 2936485-2011-00019
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- November 18, 2010
- Report Date
- November 18, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ABLATION, THE CUTTING LOOP BROKE OFF INSIDE THE PATIENT. IT WAS REPORTED THAT THE SURGEON FISHED OUT THE LOOP WITH ANOTHER INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 24FR 30 CUTTING LOOP ELECTRODE, .014 (6BX) | ELECTRODE | GEI | STRYKER ENDOSCOPY SAN JOSE | STRD101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |