MAUDE Adverse Event Report: COOK INC ATLAS-WIRE STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G32824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: (b)(6).Occupation: other non-healthcare professional: quality specialist.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a flexible ureterolithotripsy using a atlas-wire stone extractor, the wire of the basket was broken.The extractor initially captured the stone, but it was lost due to the device malfunction, and the device was then unable to capture any stones.The break was discovered inside of the patient.The complainant estimates the channel size of the scope to be 6mm.The size of the stone was approximately 0.6 to 0.8 cm.Another device was used, and the procedure was completed.No adverse effects were reported due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: it was reported, during a flexible ureterolithotripsy using a atlas-wire stone extractor, the wire of the basket was broken.The extractor initially captured the stone, but it was lost due to the device malfunction, and the device was then unable to capture any stones.The break was discovered inside of the patient.The complainant estimates the channel size of the scope to be 6mm.The size of the stone was approximately 0.6 to 0.8 cm.Another device was used, and the procedure was completed.No adverse effects were reported due to the alleged malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One atlas-wire stone extractor was returned for investigation with the handle in the open position and the basket formation in the closed position.The male luer lock adapter was loos and the collet knob was tight and secure.The polyethylene terephthalate tubing measured 1.5cm in length.The handle did not actuate basket formation.The support sheath and basket sheath were detached.Basket formation wires were broken, and charring was noted on the end of a broken wire.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which caution, ¿this device is conductive.Avoid contact with any electrified instrument.¿ examination of the returned device found charring at the end of a broken wire, indicative of exposure to a laser during use, which is cautioned against in the ifu.It was also found that the basket sheath had separated from the support sheath.This likely occurred from attempting to open/close the basket with the broken wire.The force applied to the device with a broken wire placed excessive force on the joint between the two sheaths, causing the separation.Based on the information available, cook has concluded that the broken wire was caused by exposure to a laser during use.Cook will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ATLAS-WIRE STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10599688
• Report Number: 1820334-2020-01771
• Device Sequence Number: 16951880
• Product Code: FFL
• UDI-Device Identifier: 00827002328242
• UDI-Public: (01)00827002328242(17)221113(10)10148489
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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 Expiration Date: 11/13/2022
• Device Model Number: G32824
• Device Catalogue Number: AE-432115
• Device Lot Number: 10148489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1