MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-5 100V; ENDOSCOPE REPROCESSOR

Model Number OER-5

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The lid of the subject oer-5 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating subject device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The user found the lid of oer-5 was cracked at the inspection before use.There was no reported when the crack occurred.There was no report regarding patient injury and damage of the endoscopes related to the event.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2020-01892.The lid of the subject oer-5 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed that the subject lid had a crack.The cracks were near the screw fastening part and the molding weld line.As a result of fracture surface analysis of the crack near the screw fastening part, this crack was fatigue fracture.During the following evaluation by omsc, the crack was not duplicated.- omsc repeatedly opened and closed the subject lid.- omsc applied heat to the subject lid.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause has been unknown; however, the following are supposed to be the cause of the cracks of the subject lid.- due to the strong opening and closing operation of the lid of the subject device, a strong stress was repeatedly applied to the subject lid.The instruction manual of the subject device states the corresponding method in case of an abnormality.

• Brand Name: OER-5 100V
• 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: 9901460
• MDR Text Key: 195156798
• Report Number: 8010047-2020-01892
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1