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

Catalog Number NTSE-022115-UDH

Device Problem Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.(b)(4).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 Description

It was initially reported, "did not use on a patient due to a defect to the basket." requested additional information, and on 12jul2018 the customer reported, during cystoscopy with a ureteroscopy, laser lithotripsy, the wires of the basket of the ncircle tipless stone extractor seemed to have flipped inside/out for no apparent reason, "i'm sorry i can't give any more information than that." no adverse events have been reported as a result of the alleged malfunction.

Event Description

No additional event information has been received since the last report was submitted on 25-jul-2018.

Manufacturer Narrative

(b)(4).Evaluation / investigation: the actual complaint device was not returned.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of the instructions for use, manufacturing instructions, and quality control data was conducted.A review of the device history record could not be performed as the lot number of the device was not provided.A review of complaint history could not be performed on the complaint device lot because the lot number was not provided.The instructions for use contains the following information in the precaution section: enclose the device in the sheath before removing from the tray/holder.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 complaint device was not returned, so an analysis of the device was not possible.Possible causes for the reported deformed wires could be that the wires were not formed properly during manufacturing, the wires could have been damaged during shipping, of they could have been damaged during unpacking / handling of the device.There was not enough information available to determine a likely cause for the reported issue.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7719089
• MDR Text Key: 115391907
• Report Number: 1820334-2018-02176
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU