FDA Adverse Event
Malfunction
Summary report: N
STRYKER STANDARD VIDEO CART WITH ISOLATION TRANSFORM
MDR report key: 1883267
·
Received October 20, 2010
Report
- Report Number
- 2936485-2010-00781
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- KOG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CASE THE POWER CORD CONNECTED TO THE VIDEO CART BEGAN SMOKING, MELTING BOTH CORD AND WALL OUTLET. IT WAS FURTHER REPORTED THAT THE SMOKE WAS PUT OUT AND UNIT WAS REPLACED, NO HARM TO PT OR DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER STANDARD VIDEO CART WITH ISOLATION TRANSFORM | CARTS | KOG | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |