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

Model Number	G56401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 was reported, during a pcnl (percutaneous nephrolithotomy) antegrade ureteroscopy using a perc ngage nitinol tipless stone extractor, the basket broke after only one pass in the kidney.Another device was opened and used to successfully complete the procedure.According to the initial reported, no adverse effects were reported due to the alleged malfunction.
Additional Manufacturer Narrative
It was reported, the basket broke after only one pass in the kidney.Another device was opened and used to successfully complete the procedure.Investigation evaluation: reviews of complaint history, device history record, manufacturing instructions, quality control data and the instructions for use(ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.The evidence indicated the device was made to specification.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 were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that 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: precautions: this device is conductive.Avoid contact with any electrified instrument.Excessive force could damage device.The device was not returned.The provided information stated the device "broke".Based on previous complaints, it is assumed that the basket of the device would not open and close properly, as that was the most common failure mode for the device.Without the device available for investigation, a cause for the issue could not be determined.The risk documentation procedures were reviewed, and it was determined that no actions are required.We will continue our monitoring of similar complaints.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
There is no new patient or event information to report.

• Brand Name: PERC NGAGE NITINOL 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: 9681540
• Report Number: 1820334-2020-00305
• Device Sequence Number: 16269064
• Product Code: FFL
• UDI-Device Identifier: 00827002564015
• UDI-Public: (01)00827002564015(17)220306(10)9572522
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 03/06/2022
• Device Model Number: G56401
• Device Catalogue Number: NGRE-100038
• Device Lot Number: 9572522
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR