FDA Adverse Event Malfunction Summary report: N

RESECTION SHEATH, 24 FR.

MDR report key: 3960030 · Received May 29, 2014

Report

Report Number: 9610773-2014-00021
Event Type: Malfunction
Date Received: May 29, 2014
Date of Event: May 5, 2014
Report Date: May 7, 2014
Manufacturer: OLYMPUS WINTER & IBE GMBH
Product Code: FED
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE SUSPECT MEDICAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION/ INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT YET BE DETERMINED AS THE INVESTIGATION IS STILL ONGOING. HOWEVER, AS SOON AS THE INVESTIGATION RESULTS AND FINAL EVALUATION ARE AVAILABLE, THIS REPORT WILL BE UPDATE. OLYMPUS SUBMITS THIS INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE CERAMIC INSULATION OF THE SUSPECT MEDICAL DEVICE BROKE OFF AND FELL INSIDE THE PT'S BLADDER. THE INTENDED PROCEDURE WAS REPORTEDLY COMPLETED BY USING A SIMILAR DEVICE AND NO FRAGMENTS/PARTS REMAINED INSIDE THE PATIENT AS THEY WERE RETRIEVED BY SUPRAPUBICAL APPROACH DURING A FOLLOW-UP PROCEDURE. THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT HARM OR INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
315666	RESECTION SHEATH, 24 FR.	RESECTION SHEATHS	FED	OLYMPUS WINTER & IBE GMBH		11RG

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other