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 Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

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 while the physician was performing a ureteroscopy procedure with laser lithotripsy on a patient using the ncircle tipless stone extractor device, the physician discovered that the basket broke and detached inside the patient¿s ureter.No unintended section of the device remained inside the patient¿s body.The patient did require an additional procedure due to this occurrence.The physician retrieved the broken portion of the device using a cystoscope grasper.The complainant did not report any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Device available for evaluation changed from "no" to "yes." evaluation / investigation: a review of device history record, documentation, drawings, manufacturing instructions, quality control and specifications was performed.A visual inspection of the device and functional testing was also conducted.One n circle tipless stone extractor was returned for evaluation.The device was returned with the handle in the closed position.The basket formation was not returned.The collet knob was tight and secure.The male luer lock adaptor (mlla) was tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length.The handle moves the coil assembly.With the handle in the open position, 8 mm of coil protrudes from the end of the basket sheath.The protruding coil has separation, indicating it has been pulled.Approximately 5 mm from end of basket sheath the coil elongation starts.It appears the device met resistance beyond its intended design.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 and device integrity prior to shipping.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.A device history record review was performed and noted 6 non-conformances during manufacturing.They include wire damage; items were scrapped, inadequate quality; item scrapped, damaged component ; item scrapped, failed tensile test; product scrapped, blank line in documentation; data entry completed, loose foreign matter; product reworked.A review of complaint history found there have been no other complaints received for the complaint device lot number 7202742.Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined.The root cause could be related to product use or handling.Measures have been initiated to address this failure mode.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 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: 6728091
• MDR Text Key: 80543177
• Report Number: 1820334-2017-01705
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)190816(10)7202742
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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
• Patient Outcome(s): Required Intervention