FDA Adverse Event Malfunction Summary report: N

OLYMPUS HF RESECTION ELECTRODES

MDR report key: 2870438 · Received November 13, 2012

Report

Report Number: 9610773-2012-00258
Event Type: Malfunction
Date Received: November 13, 2012
Report Date: October 15, 2012
Manufacturer: OLYMPUS WINTER & IBE GMBH
Product Code: KNS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADD¿L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE REFERENCED DEVICE WAS BEING USED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE DURING WHICH THE LOOP HAD DISINTEGRATED. THE FRAGMENTS WERE REPORTEDLY BEING FLUSHED OUT WITH AN EVACUATOR. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH AN UNSPECIFIED ELECTRODE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND THE LOOP WIRE WAS COMPLETELY DETACHED AT BOTH DISTAL ENDS WITH EVIDENCE OF DISCOLORED CHARRED STAIN AT BOTH ENDS. THE INSERTION PORTION OF THE WORKING LENGTH WAS FOUND WITH FLUID STAIN AND DISCOLORATION UPON INSPECTION. THE REFERENCED DEVICE HAD BEEN FORWARDED TO THE OEM FOR FURTHER EVAL. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

OLYMPUS WAS INFORMED THAT THE REFERENCED DEVICE BROKE OFF INSIDE THE PATIENT DURING AN UNIDENTIFIED PROCEDURE AFTER IT HAD BEEN USED FOR ABOUT AN HOUR. THE DEVICE FRAGMENT REPORTEDLY WAS FLUSHED OUT. THERE WAS NO PATIENT HARM REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS HF RESECTION ELECTRODES	RESECTION ELECTRODES	KNS	OLYMPUS WINTER & IBE GMBH	A22206C	12144P02L001

Patients

Seq	Age	Sex	Outcome	Treatment
1				OLYMPUS TELESCOPE WITH UNKNOWN MODEL/SERIAL #\| OLYMPUS UES-40 GENERATOR WITH UNSPECIFIED SERIAL #