FDA Adverse Event
Malfunction
Summary report: N
X8000 LIGHTSOURCE
MDR report key: 2141604
·
Received May 31, 2011
Report
- Report Number
- 2936485-2011-00371
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 10, 2011
- Report Date
- May 10, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT STOPPED WORKING BETWEEN PROCEDURES. IT WAS FURTHER REPORTED THAT THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES.
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 |