MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-ELITE

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse put the broken connector back together.The device was repaired to specifications.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility reported that a connector came apart on an endoscope reprocessor.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be established.It is likely the lock lever received extra stress by being pushed to connect to the connector when the user attached the connecting tube.This would cause the lock lever to break off and prevent the connecting tube from being attached.The ifu contains the following statements regarding the connecting tube that may help prevent misuse: "if there is an irregularity of the connecting tube on either endoscope, it must be corrected and both endoscopes must be reprocessed again.Otherwise, the reprocessing of endoscopes may be insufficient." olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11316776
• MDR Text Key: 233559131
• Report Number: 8010047-2021-02532
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1