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

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

Olympus received mw5147748 through fda¿s medwatch program.As per the mw report, the customer reported that "the distal cover was placed on the duodenovideoscope before procedure by registered nurse (rn) who stated out loud to the initial reporter (also an rn) that she was placing the cap on, and the initial reporter watched her place it on and give it a slight tug to make sure it was on.When doctor (dr) pulled a metal stent from the patient's bile duct, he has to pull the scope all the way out of the patient to remove the stent from the patient's body.Dr then went back in with the scope but did struggle to get the scope down the patient this time but eventually did get the scope down.When the case was complete, dr pulled the scope out and noticed that the cap was no longer on the distal end of the scope".It is unknown at this time when the distal cap fell off from the scope or where it fell off.There are currently no reports that the cover actually fell in the patient that required urgent retrieval or that any patient harm or injury occurred.This report is related to linked patient identifier (b)(6).

Manufacturer Narrative

This report is being submitted to correct h7 and h9.Please see h7 and h9 for further details.

Manufacturer Narrative

Correction to g2, other and mdr report# mw5147748 was inadvertently left out of the initial report.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Despite good faith attempts additional information from the user facility was not received.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Since it has been confirmed that the distal cover does not come off from the tip of the endoscope if attached correctly according to the procedure in the instruction manual, the loose installation of the distal cover is likely caused by the user's handling (the distal cover was not properly attached to the scope).However, it was not possible to definitively identify the root cause of the loose attachment of the distal cover.Evidence to support user handling being the cause is as follows: -as a result of the operation confirmation, it was confirmed that if the distal cover was attached in the correct procedure, it would not come off from the tip of the endoscope.-as a result of the labeling review, the ifu states that insufficient attachment was a factor in handling that caused the distal cover to come off.It is said that after attaching the distal cover to the endoscope, the customer pulled the cover to confirm that it would not come off, but it is unclear whether twisted the cover to confirm.It is also unclear whether the scope was pushed in until the hook of the scope was visible through the opening of the distal cover.Furthermore, since the actual item has not been returned, it is not possible to confirm how it was actually attached to the scope.Therefore, this factor cannot be completely denied.Evidence to support the actual product satisfies the specifications - as a result of the type test, olympus verified that the distal cover does not come off from the tip of the endoscope in the evaluation at the design change, and confirmed that the product satisfies the specifications.- in the parts supplier's inspection, after attaching the distal cover, apply a load of pushing and pulling to the distal cover, and confirm that there is no damage such as tearing or chipping, displacement of the attachment position, or falling off.The event can be prevented by following the instructions for use which state: "put your finger onto the center on the top of the distal cover and push the top of the distal cover straight onto the distal end of the endoscope until the hook of the distal ring is completely visible within the opening of the distal cover.¿ "detach the distal cover from the distal end of the endoscope when the distal cover cannot be attached to the endoscope smoothly or any incorrect attaching procedure is noticed.Refer to section 9.5, ¿detach the distal cover¿ for detaching the distal cover.With a new distal cover, repeat step 1 through 4.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: 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: 18469731
• MDR Text Key: 332987183
• Report Number: 3003637092-2024-00003
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H3125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1071-2024
• Patient Sequence Number: 1
• Treatment: TJF-Q190V - EVIS EXERA III DUODENOVIDEOSCOPE.