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 Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is not available for this event.The scope used with the device is model number tjf-q190v.The device is discarded and will not be returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure the device (distal cover) was placed on the end of the scope, until the device was not visible in the endoscopic image.At the end of the procedure when the physician removed the scope from the patient, the device was not attached to the scope.The nurse found the device (distal end cover) in the patient¿s mouth and retrieved the device.No additional methods needed to be used to find and remove the device.The procedure was completed and there was no harm or adverse impact to the patient.

Manufacturer Narrative

It was confirmed that there was no patient injury.It was confirmed prior to attaching the distal end that the outlet of the distal end was opened.The opening side of the distal cover was aligned with the lens side of the distal end of the endoscope.The distal end cover was secure prior to the procedure.The distal end cover was just removed from the patient's mouth.No delay was caused in the procedure.The patient's pre-existing conditions and patient demographics are not available.There were no cracks observed in the distal end cover.

Manufacturer Narrative

This follow up report is provided to give the manufacturer's investigation results.A sample unit from lot h0729 was tested for the described failure.We confirmed a distal cover doesn't come loose and detach as long as it has no damage and it's correctly attached to a scope.A device history record review was completed for lot h9510, and no irregularities or non-conformities were detected.The distal cover involved in the reported event was not returned.The exact cause could not be determined.According to the provided information, there were no cracks observed in the distal end cover after it was attached to the scope.The most likely cause of this failure is improper attachment.It's assumed that a distal cover was not correctly attached and fixed to the scope, and it detached unexpectedly at removal.The instructions for use warn: " never use the endoscope unless the distal cover is properly attached to the distal end.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.¿ when the endoscope is repeatedly inserted into the body cavity, always confirm that the distal cover is attached properly before insertion.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed".

Manufacturer Narrative

This report is being supplemented to provide corrected information based on a formal investigation.Also corrected g2, h4 and h6.-reconfirmation of complaint failure a reproduction confirmation was performed according to the pre-use inspection procedure in section 7.3 of the instruction manual using the sample held at the hinode plant, but it was confirmed that the indicated event was not reproduced.(lot of the maj-2315 used for reproduction confirmation: h0729) -investigation results of product specifications quality evaluations of production prototypes have verified that the tip cover will not be damaged if it is attached correctly according to the instruction manual.-sampling inspection results at the parts manufacturer the parts supplier conducts sampling inspections of 3 parts for each production lot, and confirms that the parts conform to the specifications.According to the information provided, there was no damage to the distal cover, but it is not possible to determine whether it was damaged before or after use.Based on the reproduction confirmation results, investigation results of product specifications, and the inspection results at the parts manufacturer, it is believed that the product conformed to the specifications.However, the actual product has not been returned, so the cause could not be determined.Based on the results of the investigation, the possible causes of the distal cover falling off are as follows: -it's assumed that a distal cover was not correctly attached and fixed to the scope, and it detached unexpectedly at removal.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: 10935177
• MDR Text Key: 226360543
• Report Number: 8010047-2020-09739
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• 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: H9510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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