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

Catalog Number NTSE-045065-UDH

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number- exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a choledochoscopic lithotomy, the top of the basket wires of an ncircle tipless stone extractor were broken.The device is reused.After the second disinfection, the basket is deformed.A new device was used to complete the procedure.The patient did not experience any harm as a result of this occurrence.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a ncircle tipless stone extractor.The basket of the device reportedly was found to be broken during a choledochoscopic lithotomy procedure.Further communication with the user facility clarified that the device was being reused, having been previously disinfected from the first use.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.Investigation - evaluation.A document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other complaints associated with the complaint device lot.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 complaint device was not returned.Without the device available for investigation, the exact nature and cause of the broken wire could not be determined.The device was reused, contrary to the product label and provided instructions for use, which specify the device is single use only.Since the exact nature of the broken wire could not be determined, it could also not be determined if the reprocessing caused or contributed to the breakage.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 Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 Description

There is no new patient or event information to report.

• 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: 11098836
• MDR Text Key: 227011697
• Report Number: 1820334-2020-02393
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002175201
• UDI-Public: (01)10827002175201(17)230409(10)13124814
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 13124814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR