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

Catalog Number NCT4-024115

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2017

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 area representative reported the ncompass nitinol tipless stone extractor was not fully retracting in an ureteroscopy procedure.The procedure was completed successfully using another device of the same type.No portion of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this retraction issue.As reported, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also conducted.A review of complaint history, the device history record, specifications, and trends was performed.One device was returned for investigation.The device was returned with the handle in an almost closed position and the basket formation is partially open.The collet knob is tight and secure.The male lure lock adaptor (mlla) is finger tight.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.The support sheath was found to be bowed.A visual examination noted the basket sheath has damage starting at 83.5 cm from the distal tip and extends to 85 cm from the distal tip.A functional test noted the handle actuates the basket formation to the fully deployed position, but it will not fully retract the basket formation.The complaint is confirmed.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.A review of the device history record showed no non-conformances were noted.A review of complaint history revealed this complaint to be the only reported complaint associated to the complaint lot number 7945982.Based on the provided information a definitive root cause cannot be established.Per the quality engineering risk assessment, no further action is required.Measures have been initiated to address the reported 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: NCOMPASS NITINOL 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: 6854694
• MDR Text Key: 85627172
• Report Number: 1820334-2017-02865
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002327016
• UDI-Public: (01)00827002327016(17)200526(10)7945982
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCT4-024115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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