FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 1100843
·
Received May 16, 2008
Report
- Report Number
- 2020550-2008-00010
- Event Type
- Other
- Date Received
- May 16, 2008
- Date of Event
- April 15, 2008
- Report Date
- May 15, 2008
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TWO DRS WERE PERFORMING A WRIST AND SHOULDER ARTHROSCOPY CONCURRENTLY WHEN THE SCOPE BEING USED IN THE WRIST PROCEDURE STOPPED WORKING; DR HAD NO VISUALS AND NO BACKUP SCOPE SO THE WRIST PROCEDURE WAS STOPPED AT THAT TIME. THE SHOULDER PROCEDURE WAS COMPLETED. THE PT WAS UNDER GENERAL ANESTHESIA AT THE TIME. THE WRIST PROCEDURE HAD NOT BEEN RESCHEDULED YET. THERE WAS NO OTHER PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | RIGID SCOPE | HRX | KARL STORZ GMBH & CO. KG | 28305BA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |