MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G19110
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: technical/regulatory affairs manager.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
As reported, prior to a transurethral lithotripsy (tul) using a ncircle delta wire tipless stone extractor, the physician conducted a functional check of the device, confirming that the basket could open and close.After deploying the basket and collecting ureteral stone no more than ten (10) times, the handle suddenly became immoveable.The physician stopped using the device because the basket could not be deployed anymore.After removing the device from the patient¿s body, a functional check was conducted, and it was confirmed that the handle was movable, but there was resistance.The basket became unable to be stored in the sheath.The complaint device was exchanged with another manufacture¿s device and the procedure was successfully completed.There were no adverse effects to the patient as a result of this occurrence.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, the instructions for use, and quality control data.One device was returned for investigation.Inspection of the returned device noted the device was returned with the handle in the open position and the basket formation was open.There were no kinks found within the basket formation.The handle was disassembled for investigation.One of the wires was found pulled out and that prevented the basket formation from fully retracting into the basket sheath.A drag was noted when the handle slide moved to the open and closed positions and the handle slide opening appears to narrow.The proximal end of handle slide opening measures 4 mm and the distal end of the handle slide opening measures 3 mm.Functional testing of the device noted the handle actuates the basket formation to the open position, but it does not retract completely.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a basket that would not fully close.It was observed that 1 of the 4 basket wires was broken near the proximal end of the basket.The broken basket wire would not retract into the sheath and was preventing the basket from fully closing.It was also observed that there was resistance felt when actuating the handle.The opening of the slot in the handle was measured and it was found to be 3mm minimum and 4mm maximum in width.The specification for slot width is.145 -.165 inches or 3.683 - 4.191 mm.The width of the slot in the handle was narrower than the specification.The provided information stated the device functioned normally before use.It is possible that the handle suffered internal damage during use from an unknown cause.The cause for the broken basket wire also could not be determined.It is possible the wire was exposed to a laser during use, excessive force was applied to the device, or a procedural related issue such as stone shape/size caused the wire to break.Per the quality engineering risk assessment, no further action is warranted.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event or patient information has been received since the last report was submitted on 22jul2019.

• Brand Name: NCIRCLE DELTA WIRE TIPLESS 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: 8812955
• Report Number: 1820334-2019-01751
• Device Sequence Number: 19450677
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)220315(10)9594584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 03/15/2022
• Device Model Number: G19110
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 9594584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1