FDA Adverse Event
Malfunction
Summary report: N
X8000 LIGHTSOURCE
MDR report key: 2231249
·
Received July 25, 2011
Report
- Report Number
- 2936485-2011-00520
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 5, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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, THE UNIT EXPERIENCED AN E-1 ERROR. IT WAS FURTHER REPORTED THAT THIS CAUSED A DELAY IN THE CASE. HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X8000 LIGHTSOURCE | LIGHTSOURCE | FCW | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |