MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number	MAJ-2315
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is expected to be returned to olympus for further evaluation and testing.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus the single use distal cover felt loose when attached to the scope.The customer attempted to use three different maj-2315 and re-installed tjf-q290v (evis lucera elite duodenovideoscope) three times; however, the issue persisted.The reported issue was found during preparation for a therapeutic endoscopic retrograde cholangiopancreatography.The intended procedure was completed by replacing the subject device and the scope.There were no reports of patient harm.This report is related to linked patient identifiers (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer confirmed the following information with regards to the malfunction: -the comment that it was loose meant that it was not properly attached to the scope and could easily come off.There was no damage to the tip cover.It is unclear whether the pre-use inspection was conducted to confirm that the product was installed correctly.It was also confirmed that the actual product could not be returned as it had been disposed of, and that there was a high possibility that anti-fog was not used at the facility.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the dropout was caused by insufficient attachment to the scope or chemical cracks caused by adhesion of chemicals such as anti-fogging agents, resulting in insufficient fixation to the scope.However, a definitive root cause could not be established as the device was not returned for evaluation.The suggested event can be prevented by handling the device in accordance with the instructions for use which state: "place your finger in the center of the tip of the tip cover and push it straight in until the protrusion of the tip ring fits into the opening of the tip cover." "do not apply anti-fog, olive oil, or products containing petroleum-based ingredients (such as vaseline) to the tip cover or endoscope tip.Doing so may cause cracks in the tip cover." "if the tip cover cannot be attached smoothly or if you notice a mistake in the attachment procedure, remove the tip cover and use a spare tip cover to reattach the tip cover from step 1.Make sure that the tip cover is attached securely.Otherwise, the tip cover may shift or fall off.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to correct d4 - unique identifier (udi) number to (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16899504
• Report Number: 3003637092-2023-00096
• Device Sequence Number: 11567002
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 10/04/2023; 11/29/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/04/2023; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JF-260V EVIS LUCERA DUODENOVIDEOSCOPE.; TJF-Q290V EVIS LUCERA ELITE DUODENOVIDEOSCOPE.
• Patient Sex: Unknown