FDA Adverse Event
Malfunction
Summary report: N
STORZ
MDR report key: 1951133
·
Received January 3, 2011
Report
- Report Number
- MW5018861
- Event Type
- Malfunction
- Date Received
- January 3, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 22, 2010
- Product Code
- KNS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING TURP CUTTING LOOPS BROKE X3. DATE OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: BPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ | CUTTING LOOP | KNS | 27050G | 40762 | ||
| 2 | STORZ | CUTTING LOOP | KNS | 40762 | |||
| 3 | STORZ | CUTTING LOOP | KNS | 37145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |