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

Model Number OER-PRO

Device Problem Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

The olympus field service engineer (fse) found the automated endoscope reprocessor's disinfectant circulation hoses needed to be replaced.There were foreign objects found in the chemical solution.The fse repair/replaced the disinfectant circulation hoses and the aer was verified according to original equipment manufacturer specifications.Additionally, software attributes have been verified and confirmed.Equipment passed the electrical safety test and the equipment functionality was verified before leaving the facility.The cause of the reported event could not be determined at this time as the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The technical assistance center (tac) was informed by the field service engineer (fse) that the user facility's automated endoscope reprocessor (aer) machine had an accumulation of foreign black specs in the filter.No patient injury or infection was reported.

• 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: 10524976
• MDR Text Key: 222100569
• Report Number: 8010047-2020-06447
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2020

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: No Information
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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