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

Model Number MAJ-2315

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The head nurse reported to olympus that mucosal injury occurred when the singe use distal cover was used in an unspecified procedure and a small piece of mucosal tissue was left behind the albaran lever of the endoscope.There were no reports of patient harm.Two complaints below have been created for reporting this event: related patient identifiers: complaint # (b)(4), single use distal cover; maj-2315, serial number- unknown (this complaint); complaint # (b)(4), evis exera iii duodenovideoscope, tjf-q190v, serial number- unknown.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer (see section b5).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide information received through customer follow-up.The customer confirmed the distal cap was the new design.Although the lot number of the actual product is unknown, olympus has obtained information that the design change product was used, so it was judged to be a complaint due to a design change product and an investigation was conducted.Lot number h2530 and later are design change products and are determined not to be a recalled device.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, it is likely the phenomenon "mucosal damage" was caused by the following user operations by the following: - the scope was removed while using the suction function.- the scope was removed immediately after suction.However, the root cause of the phenomenon could not be identified.The event can be prevented by following the instructions for use which state: ¿take caution applying suction when the distal end is in contact with the mucosal surface.The suction can cause the distal end to aspirate the mucosal membrane.Moving or withdrawing the endoscope under this condition may cause patient injury and/or bleeding.This can be more common while degassing in the stomach, suctioning debris, and operating in a narrow lumen (e.G., esophagus, duodenum)." to prevent patient injury and bleeding, make sure to: -only apply suction when the endoscope is stationary.-after releasing the suction valve, check the endoscopic image to confirm that the mucosal membrane is not aspirated before moving the endoscope.Releasing the suction valve might not immediately release the mucosal membrane if it becomes aspirated.¿ 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: 17093174
• MDR Text Key: 317695524
• Report Number: 3003637092-2023-00128
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DUODENOVIDEOSCOPE, TJF-Q190V, SN- UNKNOWN.