FDA Adverse Event Malfunction Summary report: N

OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE

MDR report key: 1934544 · Received December 3, 2010

Report

Report Number: 8010047-2010-00241
Event Type: Malfunction
Date Received: December 3, 2010
Date of Event: August 12, 2010
Report Date: August 16, 2010
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP
Product Code: EOQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED A COMPLETE LOSS OF IMAGE. THERE WAS EVIDENCE OF FLUID INVASION INSIDE THE DEVICE, INCLUDING CORROSION IN THE ENDOSCOPE CONNECTOR, AND ELECTRICAL CONNECTOR. THE DISTAL END COVER WAS CRACKED, AND THE LIGHT GUIDE LENS WAS CRACKED AND CHIPPED. THE DISTAL END COVER, BENDING SECTION COVER, BENDING SECTION COVER GLUE, LIGHT GUIDE LENSES, INSERTION TUBE, LIGHT GUIDE TUBE, AND ELECTRICAL CONNECTOR WERE ALL DETERMINED TO BE NON-OLYMPUS PARTS, AND THERE WAS FURTHER EVIDENCE OF NON-OLYMPUS REPAIRS ON THE DEVICE. REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS LAST SERVICED BY OLYMPUS ON (B)(6) 2007. THE DEVICE WAS REFURBISHED. BASED UPON THE INVESTIGATION RESULT, THE IMAGE DIFFICULTY WAS ATTRIBUTED TO FLUID INVASION AND THE USE OF NON-OLYMPUS PARTS AND REPAIRS COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTORS.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE	BRONCHOSCOPE	EOQ	OLYMPUS MEDICAL SYSTEMS CORP	BF-160	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1