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

Model Number OER-PRO

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse confirmed the issue and found that the right-side drawer wheel had come off.The fse re-assembled the wheel.The equipment was repaired and verified according to specifications.Software attributes were verified and confirmed.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

An endoscopy technician reported that they could not load the acecide-c on an endoscope reprocessor because they could not get the rails to line up on the detergent drawer.There was no leaking associated with this event.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This is a supplemental report to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.The legal manufacturer could not identify a conclusive root cause.The probable cause was due to stress which may have accumulated on the screw from the disinfectant bottle drawer being repeatedly opened and closed which caused the screw to loosen and fall off.Therefore, the user couldn¿t close the disinfectant bottle drawer due to the improper assembly position.

• 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: 11258507
• MDR Text Key: 234276709
• Report Number: 8010047-2021-02084
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• 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: 03/09/2021

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-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1