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

Model Number OER-PRO

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.This device was available for evaluation, though not returned.A field service engineer (fse) went on site for this issue of the device.Upon evaluation it was noted that the lid was cracked.It is likely that something was placed between the lid and rim of the basin and cracked a side section of the plastic hood.Fse replaced the lid and hood adding stickers in appropriate locations on the hood.A test cycle was run and the device completed the test cycle without reporting any error.A broken door catch was also fixed.Equipment repaired and verified according to oem instructions.Software attributes have been verified and confirmed.The covers of the oer-pro were not removed so an electrical safety check was not required.

Event Description

As reported for this event, during reprocessing the device lid was observed to be damaged.There was no patient involvement and no reported adverse impact to anyone.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The reported issue of the device was cracks in the lid.The device history record review confirmed that device conformed to specifications when shipped.The device was not repaired in the past year.Design nor structure of the device contributed to the event.Per field service engineer who went on-site, the cracked lid appears as if somebody place something between the lid and rim of the basin and cracked a side section of the plastic hood.From past investigations, such cracks were brittle fracture.Possible cause was stress on the lid by something stuck between the lid and retaining rack/washing case.It is not uncommon that in some user facilities, connecting tube is kept connecting to the reprocessor, and left on reprocessing basin.The metal part of connecting tube causes breakage of the lid for the lid is closed with the connecting tube left in the basin.Lid closed while connecting tube is placed on the basin.Lid closed while something hard, such as a scope, is placed on the retaining rack.Lid closed while washing case being placed obliquely at the retaining rack.The instructions for use includes the following statements: reprocessing operations.When closing the lid, be careful not to get the connecting tube caught between the reprocessing basin and lid and make sure the endoscopes and the washing case are not touching the lid.Close the lid after ensuring that the cover of the washing case is closed.If the endoscopes and the washing case are touching the lid, adjust their positions and close the lid.If the lid is closed while contacting the endoscopes or accessories such as the washing case and the connecting tubes, the endoscopes, the accessories and the equipment may get damaged or water leakage may result.

• 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: 10407967
• MDR Text Key: 202957532
• Report Number: 8010047-2020-05483
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1