MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RETRIEVAL BASKET V

Model Number FG-V432P

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus the single use retrieval basket v, during the endoscopic retrograde cholangiopancreatography (ercp) procedure when basket is out from distal end of endoscope (in front of papilla) wires are broken and separated from whole basket.The issue occurred during a therapeutic procedure.There are no reports of patient or user harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, a definitive root cause of the reported torn guidewire tip issue could not be determined, as the device was not returned to olympus for evaluation, however, the issue is a known phenomenon and it is possible to infer its cause.Based on similar investigations, the issue was likely due to 1) an attempt to insert the device into the endoscope while using the guide wire.2) when the angle between the distal end and the guide wire was large, the device was inserted into the endoscope, and or 3) a force exceeding the resisting force was applied to the guide wire tip, causing the tip to tear.The event can be detected by following the instructions for use (ifu) which states: when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire while holding the distal tip as shown in figure 4.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 5.This may damage the distal tip.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18372567
• MDR Text Key: 331371475
• Report Number: 9614641-2023-01976
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04953170244063
• UDI-Public: 04953170244063
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K955063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V432P
• Device Lot Number: 34K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1