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

Model Number OER-PRO

Device Problems Crack (1135); Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to the facility.The fse repaired and verified the equipment according to original equipment manufacturer's instructions.This event is under investigation.A supplemental report will be submitted when additional information becomes available.

Event Description

The customer reported the endoscope reprocessor had hairline cracks on the lid, the lid was separating, and the screws were deteriorating.It was reported the problems were first noticed during pre-test/loading.The customer reported the equipment is inspected ensure the lid is not damaged and that the packing is not separated or detached from the lid.The customer further reported that there were no error codes, no sensors went off, no leaking was noticed, the minimum effective concentration is checked daily, no problems were noted during preventative maintenance in (b)(6) 2020, and there were no observations from the last in-service in the (b)(6) 2020 timeframe.As reported, there was no patient involvement in this event.The customer is also not aware of any patient infections or scopes with positive cultures as result of this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the lid was contacted with a scope or a hard object caused by the user handling.The following is included in the instructions for use and can detect the defect, "chapter 3 inspection before use, 3.2 inspecting the lid and lid packing: before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.".

• 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: 11339284
• MDR Text Key: 232804974
• Report Number: 8010047-2021-02768
• 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: 04/06/2021

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: 01/28/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1