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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during an unspecified therapeutic procedure, when trying to scrape out a stone using the single use retrieval nitinol basket v, the stone became temporarily impacted and the wire stretched out.The stone was then released, and the procedure was completed using the same set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, it is possible that the basket could not be pulled out due to factors such as the size, hardness, and shape of the stone.The root cause of this event could not be determined.The instruction manual contains a warning to the user regarding this event.(drawing number:rk0257, revision number : 03).Determine to use this instrument in preoperative diagnosis, interoperative contrast enhancing, or after papillotomy/papillary dilation from an expert¿s viewpoint.If large, rigid or many stones are retrieved by this instrument, the basket with stones engaged may not be removed from the body cavity.Judge the use of this product from a professional standpoint after preoperative diagnosis, intraoperative contrast and papillotomy, and papilla dilation.When quarrying with this product, there is a risk that the grasping part will not be able to pull out of the body cavity while grasping large stones, hard stones, or a large number of stones.Use this instrument with a hospitalization plan ready and the understanding that, if the stone is too hard to be crushed by the mechanical lithotriptor (bml-110a-1) or bml handle v (maj-441), the instrument may become irreversibly damaged and open surgery may have to take place to remove the stone.In case the grasping part does not pull out of the body cavity while grasping the stone with this product, or if the stone cannot be crushed even when combined with the bml handle maj-441 and the lithotripsy tool bml-110a-1, prepare for the transition to surgery and use it after preparing for hospitalization.If the distal end cannot be removed from the body, refer to chapter 11, ¿emergency treatment¿, and perform open surgery or possible treatments, such as crushing the stone by using the mechanical lithotriptor (bml-110a-1) or bml handle v (maj-441) in combination with the instrument.If the grasping part does not pull out of the body cavity, refer to "10.4 what to do if the grasping part does not come out of the body cavity" and take appropriate measures such as performing surgical procedures or crushing stones in combination with the bml handle maj-441 and the lithotripsy tool bml-110a-1.When the basket does not open and/or close smoothly, do not apply force but move the forceps elevator, set the endoscope's bending angle back, or move the position of the basket until the basket opens and closes smoothly.If the action of opening/closing the basket is forced, the sheath may stretch and the resistance in operating the handle may increase.Also, the stone may not be retrieved, and/or the basket with stone engaged may become impacted in the body.If the opening and closing operation of the gripping part is heavy, do not force the opening and closing operation, but return the forceps base and angle of the endoscope to the point where the opening and closing operation can be performed without difficulty, or move the position of the gripping part.If it is forcibly operated, the sheath will be deformed and the opening and closing operation will be heavy, and the quarry may not be possible, or the gripping part may not be able to pull out of the body cavity while grasping the stone.If retrieval can no longer be performed, determine how to handle the instrument from an expert¿s viewpoint on the basis of the understanding about procedures described in chapter 11, ¿emergency treatment¿.Do not withdraw this instrument abruptly or with excessive force.This could cause perforation, bleeding or mucous membrane damage.If this product cannot be pulled out, make a judgment from a professional standpoint after understanding "10.4 what to do when the grasping part does not come out of the body cavity".Pulling out forcibly or abruptly may result in perforation, bleeding, or mucosal damage.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: 20176554
• Report Number: 9614641-2024-01802
• Device Sequence Number: 8196525
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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