FDA Adverse Event
Malfunction
Summary report: N
STANDARD VIDEO CART KIT
MDR report key: 1767587
·
Received July 19, 2010
Report
- Report Number
- 2936485-2010-00560
- Event Type
- Malfunction
- Date Received
- July 19, 2010
- Date of Event
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FXM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ACCOUNT REVIEWED THE POWER CORDS ON THEIR CARTS AND NOTICED THAT THE CABLES WERE "SPLITTING". IT WAS FURTHER REPORTED THAT THIS ISSUE MAY BE RELATED TO AGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANDARD VIDEO CART KIT | CART | FXM | STRYKER ENDOSCOPY SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |