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

Model Number OER-AW

Device Problem Mechanical Problem (1384)

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

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus service operation repair center was informed from the facility that in unspecified timing there was a crack on the lid of the subject device.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the device because the device was not returned to omsc.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.Omsc was surmised that the phenomenon occurred due to the following; the lid was cracked because of some strong impact.The instruction manual of the subject device states the corresponding method in case of an abnormality.

• 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: 10228578
• MDR Text Key: 222926460
• Report Number: 8010047-2020-03863
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: No Information
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1