FDA Adverse Event
Malfunction
Summary report: N
OPTIMIZER POLYPECTOMY SNARE
MDR report key: 5897981
·
Received August 23, 2016
Report
- Report Number
- 3007305485-2016-00085
- Event Type
- Malfunction
- Date Received
- August 23, 2016
- Date of Event
- June 13, 2016
- Report Date
- March 25, 2020
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT
- Product Code
- FDI
- PMA / PMN Number
- K820430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL SUBMISSION FAILED DUE TO ERROR IN ZIP CODE. CORRECTED AND RESUBMITTING WITH CORRECT ADDRESS. TO DATE, CONMED HAS NOT RECEIVED ANY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON COMPLETION OF THE COMPLAINT INVESTIGATION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED DURING A COLONOSCOPY USING A 000476 SNARE OVAL, THE LOOP BROKE OFF INSIDE THE PATIENT AND HAD TO BE RETRIEVED WITH FORCEPS. AS REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550890 | OPTIMIZER POLYPECTOMY SNARE | POLYPECTOMY SNARE | FDI | CONSOLIDATED MEDICAL EQUIPMENT | 201508284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |