MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problems Device Reprocessing Problem (1091); Contamination (1120)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

An olympus employee reported on behalf of a customer, a sticky liquid came out of the gif-h290 (evis lucera elite gastrointestinal videoscope), after cleaning with the facility¿s endoscope reprocessor.The event occurred during reprocessing.There was no report of patient harm associated with this event.Related patient identifier: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information, see update in h6 (type of investigation).Information was inadvertently not included on the previous medwatch.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The specific root cause of the reported problem could not be determined at this time because the device was not returned.However, it is likely foreign material remained in the device because reprocessing was not performed according to the instructions for use (ifu) by the user.The following information is stated in the instructions for use (ifu): ¿chapter 4 basic endoscope reprocessing operations 4.3 endoscope precleaning and manual cleaning immediately after each patient examination, perform bedside precleaning, clean the outer surfaces of the endoscope, brush the suction channel, flush and rinse all channels according to the step-by-step cleaning procedure described in the endoscope¿s reprocessing manual.Complete both the prescribed bedside and manual cleaning procedures.Warning always preclean each endoscope immediately after the examination.If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing.Failure to preclean will leave excessive amounts of debris adhering to the endoscope and may compromise the effectiveness of the reprocessing.It may also result in debris accumulating in the endoscope, preventing the endoscope from working correctly.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17637546
• MDR Text Key: 322113651
• Report Number: 9610595-2023-12333
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

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-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 09/21/2023
• Supplement Dates FDA Received: 09/27/2023; 09/27/2023
• 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
• Treatment: GIF-H290.; OER-4.