MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. PJF-160 RENTAL (DMY); DUODENOVIDEOSCOPE

Model Number	PJF-160
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during a therapeutic endoscopic retrograde cholangiopancreatography using this duodenovideoscope, the elevator was almost impossible to use from the beginning of the case.It felt like it was grinding at the dials and did not loosen up with a couple of drops of mineral oil.The user had to use two hands to manipulate the elevator.It made it very difficult and prolonged case.The procedure was prolonged for one hour.Multiple inadvertent pancreatic duct cannulation may have occurred as a result of the issue, as reported by the physician.The patient had very high lipase post procedure with brief period of self-resolved pain.The procedure was completed.There was no additional medical intervention required as a result of the reported problem.There were no reports of further patient or user harm associated with this event.Olympus was further informed that the patient is less than 1 year old.

• Brand Name: PJF-160 RENTAL (DMY)
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 16873828
• Report Number: 2429304-2023-00064
• Device Sequence Number: 7262431
• Product Code: FDT
• UDI-Device Identifier: 04953170433498
• UDI-Public: 04953170433498
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2023
• Report Date (Section F): 03/10/2023

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: PJF-160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown