FDA Adverse Event
Injury
Summary report: N
5.0MM X 10FT FIBEROPTIC LIGHT CABLE
MDR report key: 2782068
·
Received October 3, 2012
Report
- Report Number
- 2936485-2012-00499
- Event Type
- Injury
- Date Received
- October 3, 2012
- Date of Event
- August 28, 2012
- Report Date
- September 6, 2012
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GCJ
- PMA / PMN Number
- K935234
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, THE LIGHT CABLE WAS HOT. FURTHER, THE ACCOUNT STATED THAT THERE WAS A LIGHT LEAK AT THE CONNECTION OF THE LIGHT SOURCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM X 10FT FIBEROPTIC LIGHT CABLE | GCJ | STRYKER ENDOSCOPY SAN JOSE | 080442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |