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

Model Number	G17627
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: wolf rigid ureteroscope 4/6.Pma/510(k) #: exempt.(b)(4).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 rigid ureteroscopy procedure the ncircle tipless stone extractor basket could not be opened.The procedure was successfully completed with a new device.No additional procedures were required and there were no adverse effects to the patient as a result of this occurrence.The patient was stone free.
Event or Problem Description
No additional patient or event information as been provided since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.One device was returned.The returned packaging confirms the lot number.A visual examination notes: the device was returned completely disassembled, the basket sheath was severed 1.7 cm from tip of support sheath, the support sheath and basket sheath are still adhered, the basket sheath measures 108.3 cm in length, polyethylene terephthalate tubing [pett], pin vise, and handle returned, the collet knob and mlla [male luer lock adapter] were not returned, the basket/coil assembly measures 63.5 cm, the cannulated handle had been severed from basket/ coil assembly with 5.3 cm of the coil still attached, the cannulated handle measures 15 cm, one wire in the basket formation was broken.A review of the device history record for this lot number showed no non-conformances related to the reported failure mode.A review of complaint history revealed no other complaints associated with lot number.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.The returned device was completely disassembled, preventing a detailed investigation of the device function.Some pieces of the handle were not returned.Damage to the sheath, basket / coil assembly and basket were observed.Any of the observed damage to the device would have prevented the basket from functioning properly.A cause for the damage could not be determined.It is possible that the damage was caused during, or after the disassembly of the device.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The investigation conclusion is cause can not be established.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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.

• Brand Name: NCIRCLE 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: 8408894
• Report Number: 1820334-2019-00598
• Device Sequence Number: 14035050
• Product Code: FFL
• UDI-Device Identifier: 00827002176270
• UDI-Public: (01)00827002176270(17)211011(10)9228504
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 10/11/2021
• Device Model Number: G17627
• Device Catalogue Number: NTSE-030115-UDH
• Device Lot Number: 9228504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR