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

Model Number OER-PRO

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Olympus field service engineer (fse) was dispatched to the user facility.The device was evaluated for a broken tube connector, the user report was confirmed.The fse replaced the connector and verified the equipment.Based on the investigation, it is presumed the connector unit was dismantled by breakage/loose of the connector.It may have disconnected the connecting tube.Stress/impact may have been added to the connector toward loose direction by the user handling, and the accumulated stress might cause the breakage.We could not confirm any factor to cause the event from design nor structure of the device.Even though there was an abnormality, it is detectable by conducting the following inspection as stated in chapter 3.Inspection before use, 3.3 inspecting the connectors: "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." investigation also confirmed the subject device was shipped in accordance with specifications on the connector assembly via dhr.

Event Description

The customer contacted olympus to report the device connecting tube could not be connected.There was no report of consequence or impact to the patient.

• 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: 10995638
• MDR Text Key: 227200158
• Report Number: 8010047-2020-10256
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 12/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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