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

Catalog Number NTRSE-100038

Device Problem Break (1069)

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

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a perc ncircle nitinol tipless stone extractor, the basket "broke.The device was jammed by a stone, so laser was used.The user was not sure if the basket was broken by the laser or the stone.The user reported worry that there could be a device fragment left inside the patient because the device "looked shorter".No adverse effects to the patient have been reported as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been requested.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: section c event summary it is reported during a percutaneous nephrolithotomy using a perc ncircle nitinol tipless stone extractor, the basket "broke.¿ the device was jammed by a stone, so a laser was used.The user was not sure if the basket was broken by the laser or the stone.A ct scan was completed to ensure that no foreign body was left in the kidney.Another percncircle was used to complete the procedure.Patient is well and was discharged.No adverse effects to the patient have been reported as a result of this occurrence.Investigation - evaluation reviews of the instructions for use (ifu), manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One perc ncircle nitinol tipless stone extractor was returned for investigation without the handle.Visual exam noted the cannula measured 40.8cm.The basket formation had one broken wire, which had a melted appearance on the tip.A document-based investigation evaluation was also performed.As no product lot was provided, a review of the device history record could not be conducted.There is no evidence that nonconforming product exists in house or in field.There were no identified gaps in the manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which provides the following information: ¿suggested handling instructions for extractors and forceps 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 the tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.¿ based on the information available, investigation has concluded that, due to the melted appearance of the broken wire, the wire was likely inadvertently exposed to a laser during use, which is cautioned against in the ifu.We will continue our monitoring of similar complaints.Per the quality engineering risk assessment, no further action is required.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 Description

Additional information was received on 05aug2020: the device was tested before use.The procedure was a percutaneous nephrolithotomy.A flexible nephroscope was used.A ct scan was completed to ensure that no foreign body was left in the kidney.Patient is well and was discharged.Another percncircle was used to complete the procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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: PERC NCIRCLE NITINOL 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: 10356460
• MDR Text Key: 201592480
• Report Number: 1820334-2020-01408
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTRSE-100038
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/25/2020
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED LASER