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

Model Number OER-PRO

Device Problem Off-Label Use (1494)

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

Event Type  malfunction  

Manufacturer Narrative

An olympus representative advised the customer the maloney bougie dilator was not validated to be used in the endoscope reprocessor.The olympus representative sent a letter to the facility outlining that gastrointestinal dilators have not been validated as compatible with the endoscope reprocessor.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the facility was manually reprocessing maloney bougie dilators in the endoscope reprocessor.No patient involvement or impact to patient care was reported for this event.

Manufacturer Narrative

Additional information was provided by the customer on 10jun2021.The customer's facility does not reprocess dilators in the endoscope reprocessor.The customer was only inquiring if the endoscope reprocessors could be used for the maloney bougie dilators.This event does not constitute a complaint.This record will be re-evaluated and closed by the manufacturer.

• 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: 11947954
• MDR Text Key: 280813693
• Report Number: 8010047-2021-07172
• 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
• Report Date: 06/16/2021

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: 05/12/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MALONEY BOUGIE DILATORS