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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the physician was performing an intended lithotripsy procedure on a patient.An ncircle delta wire tipless stone extractor was used for stone extraction in the renal pelvis.The physician had no problem in manipulation of the device at the first attempt of stone extraction, however the handle of the device did not move (open or close) at the second attempt.The physician completed the procedure by using another device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: one ncircle delta wire tipless stone extractor was received for evaluation.Visual inspection of the device noted the extractor was returned with the unidex handle (udh) and the basket formation in the closed position.The basket sheath and the support sheath remain adhered.The polyethylene terephthalate tubing (pett) measured 3 cm in length.The basket sheath is smashed 8 mm from the distal tip of the basket sheath.Functional testing was performed.The collet knob is tight and secure.The udh handle does not actuate the basket formation.The customer report has been confirmed.Based on the available information a definitive root cause cannot be established.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history for this product/lot number combination revealed there has been one similar complaint for the basket would not open/close.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: NCIRCLE DELTA WIRE 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 ; 8123392235
• MDR Report Key: 6636089
• MDR Text Key: 77551236
• Report Number: 1820334-2017-01307
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)200303(10)7722726
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSED-024115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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