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

Model Number	MAJ-2315
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal cover fell off from the duodenovideoscope and into the patient in the middle of a therapeutic endoscopic retrograde cholangiopancreatography procedure.The patient's anesthesia was extended by about 15 minutes due to the additional procedure to retrieve the fallen cover.The ercp was completed with a different distal cover.There were no reports of patient harm.This report is related to the following linked patient identifier: (b)(6).
Event or Problem Description
Updated d4 to (b)(4).Mfr report #3003637092-2024-00140-1.

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: 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
• MDR Report Key: 20099444
• Report Number: 2429304-2024-0000394
• Device Sequence Number: 8072671
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024
• Report Date (Section F): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H3X12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q190V/UNKNOWN SERIAL NO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown