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

Model Number OER-PRO

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The cause of the reported event cannot be determined.As part of our investigation, an olympus field service engineer (fse) was requested to be dispatched to the user facility to observe and investigate the reported device and to provide reprocessing training.To date, the fse visit has not been finalized.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the scope connectors are popping off the grey connectors on the oer-pro device.According to the reporter, they reprocess the scope if the connectors become disconnected as they are not getting an error code.There was no user harm or injury reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).Please see updated sections.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It was reported that the scope connectors are popping off the grey connectors in the oer-pro.We are not able to determine a root cause for the reported failure.Any irregularity in the use of the connecting tubes (improper connecting ,kinking, accidental detachment, use of the wrong connecting tube will cause the oer-pro reprocessing cycle to become ineffective.Any irregularities must be corrected and fixed and device can be used to reprocess scopes once the fix is completed.The oer-pro requires routine maintenance and inspection.In addition to checks before use, the person in charge of maintenance and administration of the medical equipment at the hospital should periodically check all of the items described in this manual.If any irregularity is observed, do not use the equipment if the irregularity present, the equipment must be repaired prior to next use.Olympus will continue to monitor the field performance of this device.

• 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: 9921005
• MDR Text Key: 208350879
• Report Number: 8010047-2020-01977
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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
• Date Manufacturer Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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