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

Model Number FG-V451P

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported to olympus that the basket could not be stored inside the sheath.This occurred during a therapeutic procedure.The procedure was completed using a similar device.There were no reports of patient harm.

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.The device was returned to olympus for inspection, and the customer's allegation was confirmed.Based on the results of the investigation, it is likely that the inability to close the basket was due to deformation of the basket wire, which caused the basket to catch on the coil sheath when closing, as well as the load placed on the basket wire during quarrying.However, the definitive root cause of the event could not be determined.The event can be detected/prevented by following the instructions for use which state: do not insert the instrument into the endoscope if the basket is not fully closed.Otherwise, patient injury, such as perforation, bleeding, or mucous membrane damage could occur.It could also damage the endoscope and/or instrument.Do not forcefully insert the product, do not insert it with the grip part not completely closed, and do not insert it suddenly.It may suddenly protrude from the tip of the endoscope, leading to perforation, bleeding, mucosal damage, etc., or damage to the endoscope or this product.If insertion is difficult due to large resistance, return the angle of the endoscope and forceps base to a point where insertion is possible without strain.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 opening/closing the grip is difficult, do not force the opening/closing operation; instead, return the endoscope's forceps stand or angle to a point where you can open/close the endoscope without strain, or move the position of the grip.If you force the operation, the sheath will deform and the opening and closing operations will become difficult, making it difficult to extract the stone, or the gripping part may not be able to be pulled out of the body cavity while still holding the stone.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RETRIEVAL NITINOL 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18947240
• MDR Text Key: 338311449
• Report Number: 9614641-2024-00744
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V451P
• Device Lot Number: 3ZK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1