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

Catalog Number NTSED-024115-UDH

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

As reported, prior to use during a transurethral lithotomy, the basket sheath of a n ncircle delta wire tipless stone extractor separated.While testing the device in an uncoiled position, the basket sheath separated when the user slid the handle.The user did not apply force to the device when the sheath separated.The device did not make patient contact.Another device was used to complete the procedure.No adverse affects to the patient have been reported as a result of this occurrence.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a ncircle delta wire tipless stone extractor.The device reportedly found to have sheath damage before use during a tul procedure.Further communication with the user facility clarified that prior to patient contact, the user performed a function test of the basket.When the user slid the handle, the basket sheath was separated like falling off without resistance.According to the user, he did not apply force to the device and his handling of the device was no problem.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The device was returned in two segments and with the handle in the open position.There was approximately 1.2cm of the cannulated handle protruding from the mlla (male luer lock adapter).The mlla and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.9 cm in length.A small portion of the support sheath, measuring 1mm, remained with the handle.The basket formation segment had approximately 8mm of exposed coil.Approximately 5mm of the basket formation was protruding from the distal tip.The remaining support sheath on the basket sheath was secure and straight in appearance.There was a kink the basket sheath located 4.6cm from the distal tip.Function test noted the handle actuates over the protruding cannula.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to have a basket that was closed and the basket sheath and basket assemblies separated from the handle.Both assemblies were broken near the distal end of the handle.The supplied information stated the user was familiar with the device and handing was not an issue.All devices are inspected for functionality and damage during manufacturing and quality control checks, and are also packaged with the basket in the open position.The cause for the observed damage could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• MDR Report Key: 11228925
• MDR Text Key: 239092807
• Report Number: 1820334-2021-00162
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)230131(10)10302368
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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: 01/31/2023
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 10302368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/22/2021
• Patient Sequence Number: 1