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

Model Number	FG-V451P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found that the center wire got stuck and could not close the basket.It was found that there was a contrast agent all over the insertion site resulting in the inability to open or close the basket.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, that the retrieval nitinol basket broke when quarrying a stone inside the bile duct.It was reported that when moved it up and down to take in the stone, the strut stretched inside the bile duct and twisted into a u-shape.The issue was found during a therapeutic procedure.The customer noted that the procedure was successfully completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information including further information provided by customer and the legal manufacturer's final investigation.According to the customer, the intended procedure was an endoscopic retrograde cholangiopancreatography (ercp) and there was no delay in the procedure.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause may have been that the support wire was excessively angulated forming a loop which prevented the support wire from being retracted with the basket into the coil sheath when the control grip was pulled.However, the exact cause could not be determined.The issue can be detected/prevented by following the instructions provided in: from the instruction manual ¿ warning ·never use excessive force to operate the instrument.This could damage the instrument.·repetition of stone retrieval will deform and/or deteriorate this instrument.Deformation and/or deterioration may make it difficult to retrieve a stone or could cause the basket with stone engaged to become impacted in the body.If stone retrieval needs to be repeated in a single case, be sure to inspect the action and the appearance before each retrieval.Stop use if any abnormality (e.G., basket wire is cut or sheath is bent, etc.) is detected during the inspection.·do not open or close the basket while the forceps elevator of the endoscope is up.Otherwise, the support wire may form a loop.Do not withdraw the instrument from the bile duct while a loop is formed by the support wire.Otherwise, the looped distal end could damage the inside of the bile duct and cause mucosal injury.If a loop of support wire is observed, lower the forceps elevator, and open/close the basket.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Common Device Name: 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: 18530987
• Report Number: 9614641-2024-00123
• Device Sequence Number: 20527787
• Product Code: LQR
• UDI-Device Identifier: 04953170395321
• UDI-Public: 04953170395321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-V451P
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown