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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.This product is supposed to be destroyed when it is detached from the endoscope for preventing unintended reuse.However, the returned device was not broken.It suggests that the device was not attached to the distal end of the endoscope firmly.The device probably came off when the distal end of the endoscope hit the patient mouth.The instruction manual provides preventive measures against the reported failure mode.If additional information becomes available, this report will be supplemented.

Event Description

The user performed an endoscopic retrograde cholangiopancreatography (ercp) with the disposable distal end cover maj-2315 and an endoscope tjf-q290v.During the procedure, the maj-2315 came off the tjf-q290v at the timing the customer was withdrawing the endoscope from the patient.The maj-2315 was removed from the patient's mouth.The intended procedure was completed.There was no report of patient injury associated with this event.

Manufacturer Narrative

This report is being supplemented to provide a correction to the legal manufacturer's final investigation and a correction to d10, g2 and h6.D10, g2, h6: information added to these fields that was inadvertently not included on the initial medwatch.Visual confirmation of the actual product confirmed that the rear end of the returned distal cover was damaged but there was no damage to the distal end of the distal cover.Quality evaluations of production prototypes have verified that the distal cover will not come off from the endoscope unless the distal cover is damaged, as long as it is properly attached without any damage.The parts supplier conducts sampling inspections of 3 parts for each production lot, and confirms that the parts conform to the specifications.During an investigation of a similar complaint that occurred at the facility in the past, it was confirmed that sl cleaner (anti-fogging agent) was used at this facility.However, it is unknown on whether or not the sl cleaner was used at the time of this case.Based on the visual confirmation result, investigation results of product specifications, and the inspection results at the parts manufacturer, it is believed that the product conformed to the specifications.When removing the distal cover that is correctly attached to the endoscope, it is designed to be removed by damaging the distal cover, but the returned distal cover did not have any damage.As part of the formal investigation, the possible causes for the drop off of maj-2315 are likely to be the following: the cover was easily removed from the scope due to insufficient attachment to the scope.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• 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): EST: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 10933945
• MDR Text Key: 219524046
• Report Number: 8010047-2020-09717
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

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
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 02/20/2023; 05/03/2024
• Supplement Dates FDA Received: 02/28/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TJF-Q190V, SN # UNK.