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

Model Number PJF-160

Device Problem Physical Resistance/Sticking (4012)

Patient Problem 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.

Manufacturer Narrative

H6 health effect- clinical code: very high lipase post procedure.The subject device was a returned olympus asset.During the evaluation of the device, the user's report was not confirmed but low angulation was observed.No other evaluation findings noted during the evaluation of the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been reported by the importer under this mdr#2429304 - 2023 - 00064.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the operator of the device had difficulty manipulating the elevator control lever because the forceps elevator was difficult to raise due to the narrow intestinal tract of the pediatric patient (less than 1 year old).However, the root cause of the event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in the following section: ¿chapter 3 preparation and inspection.¿ this supplemental report includes information added to d8.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16874013
• MDR Text Key: 314615667
• Report Number: 9610595-2023-07140
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170433498
• UDI-Public: 04953170433498
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1