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 Loose or Intermittent Connection (1371); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2017

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

The distributor reported the ncircle delta wire tipless stone extractor was opened in preparation for use in an ureterorenoscopy procedure.Once it was taken out of the package, the basket was tested by opening and closing it.Then, the basket would not open again and it was noted that the handle was loose.This stone extractor was not used.It did not make patient contact.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Evaluation / investigation: a review of complaint history, the device history record, quality control data, and specifications was performed.A visual inspection and functional testing was also conducted.One device was returned for investigation.The device was returned with the handle in the open position.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.A functional test determined the handle does not actuate the basket formation.The support sheath and basket sheath are still adhered.A visual examination noted the basket sheath is smashed starting at the distal tip and extending to 1.5 cm from the tip of the basket sheath.The smashed tip most likely has contributed to the device not functioning correctly.The complaint is confirmed.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.The device history record was reviewed and one non-conformance was noted.The non-conformance was related to a label, applied incorrectly.A review of complaints revealed this complaint to be the only reported complaint associated to the complaint lot number 7601031.Based on the provided information and the investigation evaluation a definitive root cause could not be determined.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: 6853325
• MDR Text Key: 85609895
• Report Number: 1820334-2017-02863
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)200118(10)7601031
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• 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