FDA Adverse Event Other Summary report: N

OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

MDR report key: 2092893 · Received May 4, 2011

Report

Report Number: 8010047-2011-00089
Event Type: Other
Date Received: May 4, 2011
Report Date: April 6, 2011
Manufacturer: OLYMPUS MEDICAL SYSTEM CORPORATION
Product Code: FDT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THE REPORT BUT WITH NO RESULT. HOWEVER, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO REASSESS THEIR REPROCESSING PRACTICES AND THE ESS CONFIRMED THAT THE USERS WERE NOT FOLLOWING ALL THE RECOMMENDED STEPS IN REPROCESSING THE SCOPE. THE ESS PROVIDED THE USER FACILITY STAFF REPROCESSING IN-SERVICE TRAINING AND HAD ADVISED USERS TO FOLLOW ALL THE RECOMMENDED STEPS IN PROPER REPROCESSING OF THE SCOPES. THE ESS ALSO PROVIDED THE USER FACILITY A COPY OF THE REPROCESSING MANUAL. THE ESS FURTHER REPORTED THAT THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE REPORT. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVAL. A REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS SOLD ON (B)(4) 2011 AND WAS LAST SERVICED BY OLYMPUS ON (B)(4) 2007. 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 THE SCOPE WAS LEAKING BIOLOGICAL MATERIAL FROM THE DISTAL END AFTER IT HAS BEEN REPROCESSED. THE USER FACILITY WAS REPORTED NOT USING THE WASHING TUBE MODEL MH-974 DURING PRE-CLEANING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE	DUODENOVIDEOSCOPE	FDT	OLYMPUS MEDICAL SYSTEM CORPORATION	TJF-160VF	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1