MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR; ENDOSCOPE WASHER/DISINFECTOR

Model Number OER-PRO

Device Problem Material Fragmentation (1261)

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

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Following the customer's report, an olympus field service engineer (fse) was dispatched to the facility.Once there, the fse evaluated the subject device.During the evaluation, the fse confirmed that the grey connector was operating properly, it was the connector the connects the scope to the reprocessor that was damaged.The fse provided the initial reporter the replacement part number to order and repair the device.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

The customer reported that her olympus endoscope reprocessor had a broken grey connector noted during reprocessing.This event have no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that external stress was applied to the connector of the connecting tube.The user may have applied external force toward incorrect direction to the lock lever or pin.The following is included in the instructions for use (ifu) and may have helped prevent the event: "all tubes should be free of cracks, breaks, fissures, scratches, or stains." "there should be no cracks in the lock levers of connecting tube connectors." "there should be no bends or breaks in the pin of connecting tube connector." "the tube should not be easy to disconnect ones connected." olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE WASHER/DISINFECTOR
• 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: 14427961
• MDR Text Key: 300301701
• Report Number: 8010047-2022-08378
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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