MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DISTAL COVER

Model Number	MAJ-311
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifier: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during reprocessing after using a duodenovideoscope, damage to the distal cover was confirmed.Since the possibility of damage occurring inside the body during the unspecified surgery could not be ruled out, an endoscopic examination of the upper gastrointestinal tract was performed again to confirm that no rubber fragments were present.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and the reported defect (breakage of tip cover) was confirmed.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a trace on the rubber surface was detected, which indicated the device being scratched by something sharp.However, the root cause of the event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "chapter 5: operation (section 5.2) - 'attaching the distal cover to the endos' ¿ inspection".Olympus will continue to monitor field performance for this device.

• Brand Name: DISTAL COVER
• Common Device Name: DISTAL COVER
• 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: 19229979
• Report Number: 9610595-2024-09059
• Device Sequence Number: 6834247
• Product Code: FET
• UDI-Device Identifier: 04953170071393
• UDI-Public: 4953170071393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUODENOVIDEOSCOPE (TJF-260V/2800834)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown