MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 01/28/2018

Event Type  malfunction  

Manufacturer Narrative

Olympus medical systems corp.(omsc) investigated reported phenomenon with using a similar device.Omsc confirmed that twisting or pulling the cover attached on the scope didn't cause any damages as long as it's properly attached.The exact cause of the reported event could not be conclusively determined.However, omsc surmised that the distal cover was damaged when the user attached it to the scope.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During endoscopic retrograde cholangiopancreatography (ercp), the user used tjf-q190v with the subject device.When the user withdrew the tjf-q190v, the subject device fell off into the patient's esophagus.The user picked up the subject device from the patient's body.The user confirmed that the subject device was broken not only the rear end of the front cover but also the front end.There were no reports of patient injuries related to this incident.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9999809
• MDR Text Key: 203696354
• Report Number: 8010047-2020-02388
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAJ-2315
• Device Lot Number: 8523H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1