FDA Adverse Event
Malfunction
Summary report: N
EXAMINE CHOLANGIOGRAPHY CATHETERS
MDR report key: 1259525
·
Received December 9, 2008
Report
- Report Number
- 1320894-2008-00166
- Event Type
- Malfunction
- Date Received
- December 9, 2008
- Date of Event
- October 1, 2008
- Report Date
- December 9, 2008
- Manufacturer
- CONMED CORPORATION
- Product Code
- GBZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT WAS REPORTED BY CONMED DISTRIBUTOR (B) (4) WHO REPORTED THE USER FACILITY AS (B) (4). CONMED IS AWARE THAT THE 30 DAY TIMEFRAME HAS BEEN MISSED BY 5 DAYS; CONMED IS FILING IMMEDIATELY UPON THE DISCOVERY OF THIS OVERSIGHT. THE PRODUCT HAS BEEN RETURNED TO CONMED FOR EVALUATIONS AND ONCE THE INVESTIGATION REPORT IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED BY A DISTRIBUTOR THAT "DISCONNECTION AT OUTER TUBE LEVEL. THE INNER TUBE REMAINED IN THE CYSTIC CANAL. THEY TRIED TO RE-INSERT THE INNER TUBE, WHICH LED A LESION DOWNSTREAM OF CYSTIC CANAL. THIS COULD BE INJURIOUS FOR THE PT, THIS OCCURRED TWICE WITH 2 DIFFERENT OPERATORS WITH THE SAME BATCH NUMBER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXAMINE CHOLANGIOGRAPHY CATHETERS | PERCUTANEOUS INTRODUCTION CATHETER | GBZ | CONMED CORPORATION | NA | 0803241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |