FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR ADAPTER FOR US STANDARD CABLE
MDR report key: 2509312
·
Received March 22, 2012
Report
- Report Number
- 8010177-2012-00066
- Event Type
- Malfunction
- Date Received
- March 22, 2012
- Date of Event
- February 24, 2012
- Report Date
- February 26, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- GXD
- PMA / PMN Number
- K896450
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
THE ADAPTER WASN'T FITTING WITH THE BIPOLAR FORCEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR ADAPTER FOR US STANDARD CABLE | INSTRUMENT | GXD | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |