MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number	TJF-Q190V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that the cap of their evis exera iii duodenovideoscope detached during an endoscopic retrograde cholangiopancreatography procedure.According to the initial reporter, they removed the cap with a set of forceps, and use a new cap to continue the procedure with no patient harm.The report with patient identifier (b)(6) has been submitted for the maj-2315.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.Based on the results of the investigation, the root cause is unable to be determined.However, the likely cause of the event is due to the lubricant, which was used for the scope, unintentionally adhered to the distal cover.Which caused the cover to break by chemical stress.It is also likely that after they confirmed the tip of the cover was not damaged and that it was attached in the correct position, some stress was applied to the rear end of the cover.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿3.5 attaching accessories to the endoscope: attaching the single use distal cover: do not apply anti-fogging products, olive oil, or products containing petroleum-based substances (e.G., vaseline®) to the single use distal cover and the endoscope.These products may cause cracks of the single use distal cover.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.An interview was conducted by olympus with the facility as part of the root cause investigation per capa-200735.It was reported that the facility currently uses the new design of the distal cover (maj-2315).To prevent the detachment of the distal cover from recurring, the following information was confirmed during the interview: the facility reconfirms the correct operation method by contacting olympus or another expert within your facility.The facility carefully reviews and follows the instruction manual.The facility educates or continuously educates its personnel about handling methods.The facility inspects the distal cover prior to attachment.The facility uses care when attaching the distal cover, so that it does not crack.The following additional information was obtained during the interview: the detachment of the distal cover occurred while using the old design of the device.The crack was observed by the tear line when taking the distal cover (old design) out of the sterilization packaging.The facility contacted olympus and the doctors and staff were provided in-service training on multiple occasions.The facility implemented a team approach where the technicians and doctors inspect the distal cover before and after the procedure to ensure the device is correctly attached.The facility has been using the new design of the distal cover for almost 1 year, and no detachment events have been reported.It was confirmed by the facility that there has been no change in the storage method of the distal covers since experiencing the detachment issue.The distal covers are stored in their original product carton.However, some of the distal cover sterilization packs are removed from the carton and stored in a tray in the department supply room for easy access.Per the facility, endoglide lubricant (manufactured boston scientific) was applied to the distal end of the endoscope after the cover is attached.No chemicals were administered directly into the body through the forceps channel during endoscope insertion, and no chemicals were sent to the forceps channel to lubricate.Contrast was administered through the cannula during the endoscope insertion.However, no chemicals were administered orally to the patient before the inspection, and no chemicals were used during endoscope preparation and pre-use inspection.It was confirmed that a crack was observed on the distal cover before attaching the device to the endoscope.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13664285
• Report Number: 8010047-2022-03924
• Device Sequence Number: 19095427
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K202661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2024

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: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 06/29/2023; 05/15/2024
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 06/23/2022; 07/24/2023; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: MAJ-2315.
• Patient Sex: Unknown