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

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a percutaneous nephrolithotomy (pcnl) procedure that the basket failed to open and close correctly.The stone became lodged and the wire handle had to be cut apart.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the device was received with the cannula not locked into the red handle.The sheath was measured at 38cm in length.One wire appears to have been cut and was pulled from the cannula.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided a review of the returned product and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported during a percutaneous nephrolithotomy (pcnl) procedure that the basket failed to open and close correctly.The stone became lodged and the wire handle had to be cut apart.

• Brand Name: PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5894251
• Report Number: 1820334-2016-00833
• Device Sequence Number: 18982592
• Product Code: FFL
• UDI-Device Identifier: 00827002328624
• UDI-Public: (01)00827002328624(17)190422(10)6909917
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTRSE-100038
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention