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

Catalog Number NTSE-022115-UDH

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # - exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the ncircle tipless stone extractor was used during a ureteroscopy procedure.The top of the basket (the upper part) detached from the rest of the device while inside the patient.The physician used another of the same stone extractor basket to retrieve the stone as well as the other basket fragments successfully.As reported, no unintended part of the device remained inside the patient¿s body.There were no additional procedures required due to this occurrence.There were no adverse effects or consequences to the patient.

Manufacturer Narrative

Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the closed position and the basket formation was in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.8 cm in length.A visual examination noted the distal tip of the basket sheath is smashed for 3 mm.A functional test determined the handle does not actuate the coil assembly.The coil assembly was removed from the basket sheath and it was noted the basket formation was missing.One wire, measuring approximately 5 mm, protruded the coil assembly.The coils on the coil assembly has discoloration and bio matter on it.The basket formation was not returned for investigation.In the initial investigation, the assumption was the basket formation was retracted inside in the basket sheath, however, when the coil assembly was removed, it was then discovered the basket formation was no longer attached and was not returned.A review of the device history record found no non-conformances related to the reported failure mode.A review for additional complaints for this device lot revealed this is the only complaint associated to lot number 7401779.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of relevant manufacturing documents concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Devices are inspected for damage and functionality, including a pull test of the basket assembly, prior to packaging.As per the instructions for use (ifu) precaution section: do not use excessive force to manipulate this device.Damage to the device may occur.The observed damage likely occurred during handling of the device.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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
• MDR Report Key: 7330196
• MDR Text Key: 102077692
• Report Number: 1820334-2018-00470
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention