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 Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.However, the evaluation is in progress at this time.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that in unspecified timing, it was found that there was a crack on the lid of the subject device.There was no reported when the cracks had occurred.There was no report regarding patient injury and damage of the endoscopes related to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc confirmed the subject device and found that there was a crack on the lid of the subject device.Based on the appearance of the crack, there was the possibility that the reported phenomenon was attributed to the distortion of the lid of the subject device due to the inappropriate user's handling such as a forced push stress.The instruction manual of the subject device states appropriate handling.If additional information becomes available, this report will be supplemented.

• 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: 10293520
• MDR Text Key: 223496845
• Report Number: 8010047-2020-04567
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2020
• 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: 07/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1