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

Model Number OER-PRO

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

During the call with the user, tac (technical assistance customer) support notified, informed the user that the detergent lines, alcohol lines needs to be disinfected.In addition, the user needs to follow the ¿care and maintenance¿ after long-term storage section in the oer-pro ifu (instruction for use).The user once informed, reprocessed the scopes again, acknowledged that the scopes were just reprocessed in the oer-pro, still in the room and not in use.Section to follow in ifu was sent to user per request.The device is functional and no other issue was reported.

Event Description

The user called tac (technical assistance customer) support and reported that their oer-pro was not used for 30 days and it was not prepared for long term storage.The user conveyed that subsequently two scopes in the machine were ran after changing the disinfectant (acecide-c) along with alcohol and new detergent.User stated, no error encountered and the gas filters and air filters were changed.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The reported event did not occur if the user prepared necessary treatment.Design of the device or manufacturing, cannot be confirmed as factors to cause of the event.Ifu(instructions for use) states: the device can be safely stored as stated in the ifu.Preparing the reprocessor for long-term storage: when the equipment will be stored for more than 14 days, follow the procedure described in the manual.Olympus will continue to monitor complaints for this device.

• 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: 10507975
• MDR Text Key: 224632711
• Report Number: 8010047-2020-06340
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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