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

Model Number	MAJ-2315
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9999809
• Report Number: 8010047-2020-02388
• Device Sequence Number: 1933252
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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
• Operator of Device: No Information
• Device Model Number: MAJ-2315
• Device Lot Number: 8523H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1