FDA Adverse Event Malfunction Summary report: N

ENDOSCOPE REPROCESSOR

MDR report key: 10172025 · Received June 18, 2020

Report

Report Number: 8010047-2020-03462
Event Type: Malfunction
Date Received: June 18, 2020
Date of Event: May 26, 2020
Report Date: October 29, 2020
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Product Code: FEB
UDI-DI: 04953170258589
PMA / PMN Number: K103264
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE INVESTIGATION WAS COMPLETED. A DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY DEFECTS OR NONCONFORMITIES. ALL RECORDS INDICATE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED. POSSIBLE CAUSES INCLUDE: THAT THE LOAD WAS NOT PROPERLY COMPLETED, AND THE AMOUNT OF DISINFECTANT MAY NOT HAVE BEEN ENOUGH OR THAT THE LID WAS CLOSED AND LOCKED NOT ALLOWING THE LOADING PROCESS TO FINISH.

Additional Manufacturer Narrative · 1

BASED ON THE ONSITE EVALUATION, THE FIELD SERVICE ENGINEER(FSE) OBSERVED THAT THE DEVICE HAD BEEN INTERRUPTED DURING THE LOAD PROCESS WHEN THE LID WAS OPENED CAUSING THE PROBLEM. IT WAS FOUND THAT A NEW TECHNICIAN WAS HELPING OUT AND DID NOT WAIT UNTIL THE LOAD WAS COMPLETED. FSE PERFORMED A PROGRAM B AND REPLACED LCG TO MAKE SURE THE BASIN AND TUB WERE WASHED OUT. TECHNICIAN LOADED THE NEW KIT OF LCG AND PERFORMED A LOAD WITHOUT ANY ISSUES. THE CAUSE COULD BE CONTRIBUTED TO UNINTENDED USER ERROR. NO FURTHER INFORMATION WAS REPORTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO OLYMPUS UPON STARTING A LOAD, THE LCG FUNCTION ON THE FACILITY'S DEVICE WAS STUCK IN THE LOAD LCG FUNCTION. THERE WAS NO PATIENT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
632324	ENDOSCOPE REPROCESSOR	ENDOSCOPE REPROCESSOR	FEB	OLYMPUS MEDICAL SYSTEMS CORP.	OER-PRO		04953170258589

Patients

Seq	Age	Sex	Outcome	Treatment
1