FDA Adverse Event
Malfunction
Summary report: N
24 FR 30 DEGREE CUTTING LOOP ELECTRODE, .012 (6BX)
MDR report key: 1850435
·
Received September 21, 2010
Report
- Report Number
- 2936485-2010-00722
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HYSTEROSCOPIC MYOMECTOMY, THE WIRE LOOP OF THE UNIT BROKE OFF AND FELL INTO THE PATIENT. IT WAS FURTHER REPORTED THAT THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE DOCTORS ARE ALLEGEDLY WORKING ON A PLAN TO RETRIEVE THE BROKEN WIRE LOOP FROM THE PATIENT, WHICH WILL REQUIRE A POSSIBLE SECOND SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 24 FR 30 DEGREE CUTTING LOOP ELECTRODE, .012 (6BX) | ELECTRODE | GEI | STRYKER ENDOSCOPY SAN JOSE | STRGH02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |