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

Model Number OER-PRO

Device Problem Disconnection (1171)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) worked with the customer to determine the cause of the reported issue.The customer was advised to not continue using the two connectors and to order replacement ones.No information has been obtained if the parts were replaced.If additional information is obtained a supplemental report will be filed.

Event Description

An olympus field service engineer reported that the scope connectors on an endoscope reprocessor intermittently become disconnected.There was no patient involvement or injuries reported.No additional information has been obtained.

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, it is likely the glue on the threaded part that fixed the scope-side connector became weak due to the accumulation of mechanical stress by long-term use and deterioration over time, leading to be loosened and broken.Therefore, the connecting tube was disconnected from connecting tube connector during reprocessing cycle.The defects can be detected by performing the following inspections outlined under section 4.10 'removing the endoscopes' in the instructions for use, "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.The irregularity must be corrected, and the endoscope must be reprocessed again under correct conditions.".

Manufacturer Narrative

This report is being supplemented to provide additional information received from the customer by email on 10mar2021 from rn stephanie hawkins.According to stephanie, the metal connector was falling apart during reprocessing.The equipment is inspected to ensure all equipment is functional and that all parts are present.She was unable to provide the serial number of connector that had fallen apart.There were no positive cultures or patient infections as a result of this event.There were no leaks associated with this event.The last pm of the oer-pro was 1/7/2021.There are no photos available of the disconnected scope connectors.The minimum effective concentration is being checked before each cycle.This event caused a delay in the reprocessing by 26 minutes.Pre-cleaning is performed immediately after a procedure.Pre-cleaning procedure begins in the procedure room ¿ endozime sponge for outside and endozime injected into channel and placed in bio bag and taken to decontamination.In decontamination, scope is placed in endozime channel bath and injected.The scope¿s working element is disassembled and cleaned.It¿s soaked for 2 minutes.The reported issue has been resolved with a new purchase of new scope connectors.

• 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: 11266825
• MDR Text Key: 229910841
• Report Number: 8010047-2021-02137
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 03/10/2021
• Supplement Dates FDA Received: 03/01/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1