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

Model Number OER-PRO

Device Problems Fracture (1260); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance an olympus field service engineer (fse) confirmed the user facility report.The fse found that the upper tab on one of the yellow scope connectors in the basin was chipped.Additionally, error e05 was observed.The fse replaced the yellow connector due to damage and the e05 error was resolved by replacing the tub fluid level sensor.The device was repaired and verified according to original equipment manufacturer (oem) instructions and the unit passed functional testing.Olympus will continue to monitor the field performance of this device.

Event Description

During preventative maintenance inspection, the connectors on the device were found to be damaged and displayed a intermittent error code e05.There was no patient involvement associated with this report.

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: ¿check the following for each connector.The connector should be fixed firmly the o-rings should be free of abnormalities such as cracks, tears, or dents.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the connecting tube could not be connected, because the yellow connector was broken.The breakage of the connector may have been due to stress being added to the connector by the user handling, and the accumulated stress toward loose direction.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10516533
• MDR Text Key: 223649810
• Report Number: 8010047-2020-06396
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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: Health Professional
• Device Model Number: OER-PRO
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1