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 Type  malfunction  

Manufacturer Narrative

Olympus field service engineer (fse) confirmed that a cracked push plate was found while performing preventive maintenance.The device was repaired on site and verified that it was working as specified.The equipment passed the electrical and safety tests.If additional information is obtained a supplemental mdr will be filed.

Event Description

A technician reported that an endoscope reprocessor required repairs on a cracked lid found during preventive maintenance.No patient injury was reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿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.¿ the root cause was not determined.Probable causes are that the lid was contacted by a scope when it was closed and/or something hard hit the lid causing the damage.

• 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: 10454216
• MDR Text Key: 204398782
• Report Number: 8010047-2020-05898
• 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
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1