FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL REDUCER 5/10/12MM
MDR report key: 892107
·
Received October 24, 2006
Report
- Report Number
- 1320894-2006-00090
- Event Type
- Malfunction
- Date Received
- October 24, 2006
- Date of Event
- January 1, 2006
- Report Date
- October 2, 2006
- Manufacturer
- CONMED CORPORATION
- Product Code
- FBQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION RESULTS ON THE RETURNED PRODUCT CONCLUDED THAT THE PRODUCT WAS ASSEMBLED PROPERLY. HOWEVER, THE SEAL WAS TORN AND IT WAS CONCLUDED THE INSERTION OF AN INSTRUMENT THROUGH THE CANNULA CAUSED THE SEAL TO STRETCH BEYOND ITS DESIGN AND TEAR. THE INVESTIGATION IS COMPLETED, AND THE COMPLAINT CLOSED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PIECES OF THE CORE RUBBER 3 HOLE REDUCER FELL OFF INTO THE PATIENT. PIECES WERE RETRIEVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL REDUCER 5/10/12MM | UNIVERSAL REDUCER | FBQ | CONMED CORPORATION | NA | 0604261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |