FDA Adverse Event
Injury
Summary report: N
STORZ CUTTING LOOP
MDR report key: 1100628
·
Received August 6, 2008
Report
- Report Number
- MW5007914
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 23, 2008
- Report Date
- August 6, 2008
- Manufacturer
- KARL STORZ ENDOSCOPY AMERICA INC.
- Product Code
- FAS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MD WAS USING 24 FR LOOP. TWO LOOPS BROKE WHILE INSIDE PATIENT'S BLADDER. FIRST PIECE RETRIEVED BY MD. SECOND PIECE WASHED OUT OF BLADDER WITH IRRIGATION. NO PIECES REMAINED IN PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ CUTTING LOOP | STORZ CUTTING LOOP | FAS | KARL STORZ ENDOSCOPY AMERICA INC. | 34383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |