FDA Adverse Event Malfunction Summary report: N

OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

MDR report key: 1850439 · Received September 21, 2010

Report

Report Number: 8010047-2010-00176
Event Type: Malfunction
Date Received: September 21, 2010
Date of Event: August 20, 2010
Report Date: August 24, 2010
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Product Code: FDS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER FACILITY'S REPORT OF A COMPLETE LOSS OF IMAGE. THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION, AND THE IMAGE WAS LOST EARLY IN THE TESTING PROCESS. THE DEVICE FAILED LEAK TESTING DUE TO A DAMAGED BIOPSY CHANNEL, AND THE GLUE AROUND THE BENDING SECTION COVER WAS DISCOLORED AND PEELING. THERE WERE MULTIPLE SCRATCHES AND BUCKLES FOUND ON THE INSERTION TUBE, WITH CRACKS ON THE OBJECTIVE AND THE LIGHT GUIDE LENSES. ADDITIONALLY, THE DEVICE FAILED THE DISTAL COVER INSULATION TEST DUE TO A CRACKED DISTAL END COVER. THE DEVICE HAS BEEN REFURBISHED. THE EXACT CAUSE OF THIS PHENOMENON COULD NOT BE DETERMINED, HOWEVER BASED UPON THE DAMAGE FOUND ON THE DEVICE, USER HANDLING CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY THE USER EXPERIENCED A TOTAL LOSS OF IMAGE. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED USING A DIFFERENT, BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE	COLONOSCOPE	FDS	OLYMPUS MEDICAL SYSTEMS CORPORATION	PCF-Q180AL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1