FDA Adverse Event
Malfunction
Summary report: N
5CM, 33CM PEEK MONOPOLAR HANDLE 33CM
MDR report key: 2962000
·
Received January 22, 2013
Report
- Report Number
- 2936485-2013-90027
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 27, 2012
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. NOTE: THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT WAS RECEIVED BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31652 | 5CM, 33CM PEEK MONOPOLAR HANDLE 33CM | KOG | STRYKER ENDOSCOPY SAN JOSE | 1241405D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |