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

Model Number OER-PRO

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

The event date is (b)(6) 2021, when the fse went onsite and noted the foreign material/debris in the oer-pro.As part of our investigation, while onsite the fse inspected all the tubing and other parts of the oer-pro.The fse reported that after subsequent hose replacement and several cycles - the unit ran without any debris.The fse reported that there are still parts to be installed; however, the customer has been unresponsive to attempts to schedule additional repairs.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Event Description

The customer reported brown and black liquid around the drain port in the basin of the oer-pro.An olympus field service engineer (fse) was dispatched to the customer¿s site on (b)(6) 2021 to inspect the oer-pro.The fse discovered pieces of tubing from the oer-pro that was residually resting inside of the drain port mesh filter.The fse reported that this had no effect to reprocessing equipment.There was no patient infection reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g3, h2 and h10.Additional information from the ess states during an follow-up visit on september 01, 2021, the oer -pro appeared to have been repaired.The ess reported that the customer will monitor on a per cycle basis to ensure the black debris did not reappear.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer (lm) investigation.Please see the updates in sections: g4, g7, h2, h4, h6 and h10.The legal manufacturer cannot conclusively specify the cause of the suggested event as the actual device was not returned and the origin of the debris was unknown.The legal manufacturer reported it was presumed that the inner wall of the equipment hose finely peeled off and came out as black debris during reprocessing.The legal manufactured confirmed via dhr that the subject equipment was shipped in accordance with specifications.

• 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: 12228047
• MDR Text Key: 263568438
• Report Number: 8010047-2021-09369
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 08/18/2021; 09/01/2021
• Supplement Dates FDA Received: 08/20/2021; 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1