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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

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

It was reported that the ncompass nitinol tipless stone extractor would not open during prep.They pulled a second device and it worked successfully.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

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, instructions for use, quality control data, and specifications was performed.One device was returned for investigation.The device was returned with the handle and the basket formation in the closed positions.The collet knob is tight and secure.The male luer lock adaptor (mlla) is finger tight.The polyethylene terephthalate tubing (pett) measures 2.3 cm in length.A visual examination noted that 3 mm of the cannulated handle is protruding from the collet knob.The support sheath is bowed in appearance.The distal tip of the basket sheath appears slightly smashed.A kink was noted in the basket sheath 88 cm from the distal tip.With the handle in open position, 4 mm of the basket formation protrudes from the end of the basket sheath.The handle was disassembled.The support sheath and basket sheath are still attached.The basket formation can be manually actuated; but it is a stiff transition through the bowed support sheath.The handle was reset and the device functioned properly.A review of the device history record showed no non-conformances associated with the reported failure.A complaint history search revealed to be the only complaint associated with complaint lot # 8627166.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 complaint device was found to have a basket that was closed and could not be opened.The support sheath near the handle was bowed severely and kinks were observed in the sheath.A portion of the cannulated handle also extended out of the proximal end of the handle.It is likely the observed damage occurred from handling device prior to use.With the support tube bent and the sheath kinked, the force applied to the handle could not open the basket.The cannulated handle likely moved proximally out of the handle as observed due to the force of attempting to open the basket.These devices are inspected for functionality and damage prior to packaging and packaged with the basket open.The condition of the returned device makes it likely that it was damaged when removing it from the package, or during subsequent handling.The likely cause for this issue was product use or handling related ¿ the product received excessive pressure.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.

Event Description

It was reported that the ncompass nitinol tipless stone extractor would not open during prep.They pulled a second device and it worked successfully.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

• 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
• MDR Report Key: 7605233
• MDR Text Key: 111172604
• Report Number: 1820334-2018-01693
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002327016
• UDI-Public: (01)00827002327016(17)210227(10)8627166
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

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 Expiration Date: 02/27/2021
• Device Model Number: N/A
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 8627166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1