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

Model Number G46206

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: 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 during a ureteroscopy to remove a stone located in the upper ureter three ncircle tipless stone extractors were used.The first was damaged due to off-label use (patient reference (b)(6)).While the second ncircle tipless stone extractor was in the patient's ureter it was discovered that a basket wire was bent, frayed and would no longer allow the basket to open.No portion of the damaged basket was left within the patient.The procedure was completed with another ncircle tipless stone extractor.It was reported that the patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information has been received since the last report was submitted on 30sep2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted the device as returned with the handle in the open position and the basket formation in the closed position.The mlla (male luer lock adapter) was loose, and the collet knob was tight.Visual examination also noted that the distal tip of the basket sheath was curved 5 mm from the distal tip.The basket sheath was severed 54.2 cm from the distal tip.When the hand is in the open position, the coil assembly protruded the severed area in a loop, but when the handle is in the closed position the coil does not protrude.There was also discoloration on the coil.Functional testing noted the handle does not actuate the basket formation.A review of the device history record 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.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 returned device was found to have a basket that was closed and could not be opened due to sheath damage.The basket sheath was separated approximately half way along its length.The separated sheath was preventing the basket from opening.It appears the sheath of the device may have been inadvertently kinked during use.The kink weakened the sheath until it became separated.With the location of the damage being approximately half way along the length of the basket sheath, it is possible the sheath was kinked while feeding it into the scope.Although inadvertent damage during use is possible, there is not enough evidence to definitely conclude handling damage was the cause of the device damage.Most probable cause cannot 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 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: 9134922
• MDR Text Key: 176586844
• Report Number: 1820334-2019-02453
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)220814(10)9948211
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Model Number: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9948211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1