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

Catalog Number NTSE-030115-UDH

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The physician wanted to use the ntse-030115-udh to perform a ureteroscopic lithotripsy procedure; however, the basket wire separated while in surgery.It was changed to a new one of the same product to finish procedure.The reporter is unable to confirm if the wire was retrieved.

Manufacturer Narrative

(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

The physician wanted to use the ntse (ncircle tipless stone extractor) to perform a ureteroscopic lithotripsy procedure; however, the basket wire separated while in surgery.It was changed to a new one of the same product to finish procedure.The reporter is unable to confirm if the wire was retrieved.

Manufacturer Narrative

(b)(4).Device had not been evaluated at the time of the previous report.However,it was inadvertently indicated as ¿yes¿.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.One ncircle tipless stone extractor was returned for failure analysis.A visual examination noted the basket formation was broken and not visible.A functional test was performed and the handle does not actuate the basket formation.The basket sheath was found to be smashed 1 cm from the distal tip and the tip is curved at an angle.The handle was disassembled.The basket formation could not be manually actuated.Under magnification, extreme damage is noted to the distal tip of the basket sheath.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5787101
• MDR Text Key: 49375410
• Report Number: 1820334-2016-00658
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002176270
• UDI-Public: (01)00827002176270(17)180206(10)5635261
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-030115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided; 06/20/2017
• Supplement Dates FDA Received: 10/20/2016; 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other