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

Model Number N/A

Device Problem Break (1069)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: asc manager.Pma/510k #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the basket of a ncircle tipless stone extractor was found to be broken prior to a ureteroscopy procedure.The device did not make patient contact and another similar device was used to complete the procedure.No known adverse effects to the patient have been reported.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.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.There is no evidence to suggest the product was not made to specifications.A review of the device history record 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 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.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.A search of the our database found that all devices from the device lot have been shipped, therefore, no similar product from the same lot was available for investigation.The complaint device was not returned and no photos were provided.The provided information stated that the basket broke.There was no further information provided to allow the exact nature of the issue to be determined.Based on the information that was provided, it was assumed the device experienced a broken basket wire during use.Without the device returned, a determination of the cause for the broken basket wire could not be determined.Possible causes for a broken basket wire include: exposure of the wire to a laser during use, attempting to remove too large of a stone through the scope, or excessive force applied to the device during handling / use.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

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: 8912364
• MDR Text Key: 155009754
• Report Number: 1820334-2019-02053
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)220614(10)9811258
• 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: 09/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 9811258
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1