FDA Adverse Event
Malfunction
Summary report: N
1188HD CAMERA HEAD
MDR report key: 1933978
·
Received December 1, 2010
Report
- Report Number
- 2936485-2010-00900
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- November 19, 2010
- Report Date
- November 19, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FWB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
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 CASE, DIFFERENT PROBLEMS AROSE FROM THE EQUIPMENT. FOR EXAMPLE, PROBLEMS INVOLVING THE CAMERA INCLUDE THE FOLLOWING: THE PICTURE WAS GREEN, BLACK, OR GRAINY; THE CAMERA WOULD NOT TAKE PICTURES; THE SHUTTER DID NOT WORK. THE LIGHTSOURCE TURNED OFF DURING THE CASE. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1188HD CAMERA HEAD | CAMERA | FWB | STRYKER ENDOSCOPY SAN JOSE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |