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

Model Number PJF-160

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2023

Event Type  Injury  

Event 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)
• Type of Device: 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
• MDR Text Key: 314614577
• Report Number: 2429304-2023-00064
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170433498
• UDI-Public: 04953170433498
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2023,05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other