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

Model Number N/A

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

(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 that the ncircle tipless stone extractor broke inside the patient during a ureterolithotripsy.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, and quality control data.One device was returned for investigation.The device was returned in five pieces; the handle, the basket sheath segment, coil assembly segment, support sheath segment, and the basket formation.A visual examination noted that the cannulated handle extends the handle 1.6 cm from the end of the handle.The connecting cap was not returned.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.5 cm.Only the flare of the support sheath remains on the cannulated handle.The support sheath segment measures 9.1 cm in length.The support sheath and basket sheath are still adhered.The basket sheath segment measures 107 cm in length.There are no kinks in the basket sheath segment.The tip has a slightly smashed end hole formed into an oval shape.The coil assembly is in two segments; the coil and the inner wires.The basket formation segment has the cannula and two wires extending the proximal end 5 mm.A review of the device history record found there were no non-conformances related to the reported failure mode.A complaint history search revealed this complaint is the only one associated with lot number 7939018.Per the instructions for use (ifu), precaution section: enclose the device in the sheath before removing from the tray/holder.Do not use excessive force to manipulate this device.Damage to the device may occur.A review of relevant manufacturing documents was conducted.It was 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.The returned device was found to be severely damaged.Both the sheath and basket subassembly have separated from the handle and the basket subassembly is separate from the sheath.It appears that the device was broken near the handle during use, preventing the handle from operating the basket.Devices are inspected for damage and functionality prior to packaging.It is likely the observed damage occurred during handling/use of the device.The ifu contains cautions about manipulating the device to prevent damage.The likely cause for this issue was product use or handling related - product received excessive pressure.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

It was reported that the ncircle tipless stone extractor broke inside the patient during a ureterolithotripsy.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device was tested prior to use.Another extractor was opened to remove the separated part from the patient.A new product was opened to complete the procedure.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7583377
• MDR Text Key: 110578133
• Report Number: 1820334-2018-01687
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200523(10)7939018
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 7939018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• 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