FDA Adverse Event
Injury
Summary report: N
1188HD CCU
MDR report key: 1416238
·
Received July 17, 2009
Report
- Report Number
- 2936485-2009-00077
- Event Type
- Injury
- Date Received
- July 17, 2009
- Date of Event
- June 17, 2009
- Report Date
- June 17, 2009
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FXM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
ALLEGEDLY, AFTER A CASE A NURSE WAS UNPLUGGING A CAMERA FROM THIS UNIT, AND WAS SHOCKED ON HER RIGHT HAND LEAVING A SMALL BURN MARK ON THE TIP OF HER MIDDLE FINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1188HD CCU | CAMERA CONTROL UNIT | FXM | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |