FDA Adverse Event Malfunction Summary report: N

SINGULAR POLYPECTOMY SNARE

MDR report key: 796482 · Received December 8, 2006

Report

Report Number: 1223688-2006-00026
Event Type: Malfunction
Date Received: December 8, 2006
Report Date: November 9, 2006
Manufacturer: CONMED ENDOSCOPIC TECHNOLOGIES
Product Code: FDI
PMA / PMN Number: K820430
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT IS INCONCLUSIVE AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK SO A DHR REVIEW IS NOT POSSIBLE. A SEARCH OF THE COMPLAINT DATABASE FROM 12/8/20005 TO 12/8/2006 FOUND NO OTHER COMPLAINT FOR THE SAME END ITEM AND COMPLAINT DESCRIPTION. (LOT NUMBER OF DEVICE IS UNK) NO DHR REVIEW IS POSSIBLE WITHOUT A VALID LOT NUMBER. NO CAPA REQUIRED OF THE COMPLAINT HAS NOT BEEN CONFIRMED AS MANUFACTURING RELATED. THE COMPLAINT DATABASE WILL BE MONITORED FOR FURTHER OCCURRENCES.

Description of Event or Problem · 1

DOCTOR WENT IN WITH THE SNARE TO PULL OUT A PLASTIC STENT. WHEN HE STARTED PULLING UP THE STENT, THE WHOLE LOOP OF THE SNARE BROKE OFF IN THE PATIENT. DOCTOR HAD TO GO BACK IN WITH ANOTHER DEVICE TO PULL OUT THE STENT AND THE SNARE. NO SAMPLE IS BEING RETURNED AT THIS TIME. HOSPITAL IS DOING AN INCIDENT REPORT/RISK ANALYSIS. TOLD SALES REP THAT THEY WOULD TRY TO RETURN THE DEVICE ONCE THEY COMPLETED THEIR ANALYSIS. SALE REP IS GOING TO SEE IF THEY CAN GIVE HIM THE LOT NUMBER FROM THEIR PAPER WORK. AS OF 12/8/06 COMPANY SALES REP HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE LOT NUMBER AND THE DOCTOR'S NAME WHO PERFORMED THE PROCEDURE. THE FACILITY HAS NOT RESPONDED TO ANY OF HIS REQUESTS. (NO PATIENT HARM)

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SINGULAR POLYPECTOMY SNARE	SNARE	FDI	CONMED ENDOSCOPIC TECHNOLOGIES	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	*