FDA Adverse Event
Malfunction
Summary report: N
FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED)
MDR report key: 2251133
·
Received August 9, 2011
Report
- Report Number
- 2936485-2011-00568
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- July 25, 2011
- Report Date
- July 25, 2011
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE COMPLETION OF AN ARTHROSCOPIC PROCEDURE ON THE SHOULDER, THE OUTFLOW FUNCTION ON THE UNIT WAS NOT WORKING PROPERLY. IT WAS FURTHER REPORTED THAT THE PT WAS ADMITTED TO THE ICU POST OPERATIVELY FOR OBSERVATION DUE TO EXTRAVASATION OF THE FLUID FROM THE SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED) | PUMP | HRX | STRYKER ENDOSCOPY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |