FDA Adverse Event
Injury
Summary report: N
X7000 XENON LIGHTSOURCE
MDR report key: 1113157
·
Received August 12, 2008
Report
- Report Number
- 2936485-2008-00066
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- February 22, 2008
- Report Date
- July 11, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GCT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT RETURNED FROM THE OR PROCEDURE WITH A WOUND TO THE LATERAL ASPECT OF THE LEFT HAND. IT WAS REPORTED THAT WOUND INCLUDES "BRONISH/YELLO" AREAS TO OUTSIDE ASPECT OF LEFT HAND AND TIPS OF TWO FINGERS. DR'S NOTE LISTS WOUNDS AS SECOND DEGREE WOUNDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X7000 XENON LIGHTSOURCE | LIGHTSOURCE | GCT | STRYKER ENDOSCOPY SAN JOSE | 05F022644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |