FDA Adverse Event
Malfunction
Summary report: N
988 CAMERA CONTROL UNIT
MDR report key: 2371639
·
Received December 5, 2011
Report
- Report Number
- 2936485-2011-00975
- Event Type
- Malfunction
- Date Received
- December 5, 2011
- Date of Event
- November 7, 2011
- Report Date
- November 7, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FXM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PICTURE ON THE UNIT FREEZES OR DISAPPEARS, FURTHER, PURPLE OR GREEN STRIPES ARE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 988 CAMERA CONTROL UNIT | CAMERA CONTROL UNIT | FXM | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |