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

Catalog Number NTSED-024115-UDH

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During check in of the returned complaint device related to mfr.Report # 1820334-2017-04332, it was discovered there were 2 additional devices returned in the same bag.The two additional ncircle delta wire tipless stone extractors returned are from lot number (8208646).The two ncircle delta wire tipless stone extractors were returned with a handwritten note attached from the physician.The note stated, ¿the basket feels loose and will not close".The customer has been contacted for additional patient, device and event details.At the time of this report, there has been no additional information received.

Manufacturer Narrative

Two devices were returned for investigation.Device 1; a visual examination noted the basket assembly and the basket sheath is separated from the handle.The support sheath is separated 2 mm from the mlla (male luer lock adaptor) and is separated from the basket sheath.The coil assembly protrudes 62 cm from the basket sheath.A review of the basket formation noted all of the basket wires are intact and secured in the cannula.The collet knob on the handle is tight and secured.The mlla is loose.The pett measures 3 cm in length.Device 2: the device was returned with the handle in the open position.The basket formation is in the closed position with 5 mm extending beyond the end of the basket sheath.The collet knob is tight and secure.The mlla is tight.The pett measures 3 cm in length.A functional test determined the handle does not actuate the basket formation.A visual examination noted a severe kink in the distal tip of the basket sheath.The basket formation cannot be manually actuated.No patient harm was reported.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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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
• MDR Report Key: 7221028
• MDR Text Key: 98403592
• Report Number: 1820334-2018-00077
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)200911(10)8208646
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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 Catalogue Number: NTSED-024115-UDH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1