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

Model Number	G48294
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 ws reported, during an unspecified procedure using a ngage nitinol stone extractor, the basket could not fully open.The basket could not open to its maximum diameter.Another device was used to complete the procedure.No adverse effects were reported due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5.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, the instructions for use, manufacturing instructions, 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 partially open.The width of the basket formation measured 8mm and had a burned appearance.The wires appeared blackened.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 3.6 cm in length.Functional testing noted the handle does no actuate the basket formation.The handle was disassembled.The handle could be manually actuated to the open position, but could not be manually closed completely.The basket formation was bent at the base of the support sheath.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.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.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 was partially open and could not be opened or closed using the handle of the device.The basket was observed to be damaged and discolored.The basket appeared to be blackened and possibly burnt, with the basket wire sheaths being discolored, melted, and torn.Slight damage to the basket sheath was noted near the handle.It appears the damage to the basket was preventing the basket from opening and closing properly.The cause for the damage could not be determined.The burnt and melted appearance of the basket could indicate the device was exposed to a heat source or electrical energy.The provided information stated that the device would not fully open before use.It is possible the observed thermal damage occurred during use and was not the cause for the failure of the basket to function normally.A cause for the issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.
Event or Problem Description
Additional information was received on 17dec2019: the physician confirmed the basket could not be fully opened prior to use, but he attempted to use it during the procedure.He tried several times to collect stones but was unsuccessful.

• Brand Name: NGAGE NITINOL 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: 9451398
• Report Number: 1820334-2019-03085
• Device Sequence Number: 11370516
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)221007(10)10065378
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 10/07/2022
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: 10065378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 79