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

Model Number G17520

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a stone removal at left kidney and percutaneous nephrolithotomy procedure on a (b)(6) year-old male patient using a ncircle tipless stone extractor, the sheath detached from the device near the handle.The user noticed the sheath was detached during the procedure.The same issue occurred with the second and third similar devices from the same lot.The procedure was eventually completed by using forceps to remove the stone.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.Three devices were returned for investigation.Inspection of device a noted the device was returned with the handle in the open position.The basket formation was retracted in the basket catheter.The mlla (male luer lock adapter) was loose and the collet knob was tight and secure.The basket sheath was severed 1 mm from the nose of the mlla.The basket sheath was smashed with a pinched appearance 1 cm from the distal tip.The coil assembly was removed from the sheath for evaluation and found to be offset from the cannulated handle.The basket formation was intact.Debris was found on the device from use.The points of separation had a melted appearance.Inspection of device b noted the device was returned with the handle in the open position.The basket formation was retracted in the basket catheter.The mlla and the collet knob were tight.The basket sheath was severed.0.5 mm from the nose of the mlla.5.5 cm of the coil assembly were exposed between points of separation.The basket sheath was smashed with a pinched appearance 2 cm from the distal tip.The coil assembly was removed from the basket sheath for evaluation and was found to be offset from the cannulated handle.Debris was found on the device form use.The points of separation have a melted appearance.Inspection of device c noted the device was returned without the handle assembly or the basket sheath.The coil assembly and the basket formation were returned.The coil was found to be offset.The length of the coil assembly returned measured 54 m in length.The remaining coil assembly was not returned.The proximal end of the coil assembly has a cut appearance.The basket assembly was firmly attached.A review of the device history record found no non-conformances.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that 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.All three returned devices were found to be non-functional due to damage to the sheath area near the handle: two complete devices were returned that were found to have the sheath damaged and separated near the handle.For the third device, only the basket assembly was returned, the handle and sheath were not returned.It appears the damage near the handle was severe enough to cause the basket coil to break near the handle.All 3 devices were found to have damage to the basket coil near the handle.The damage to all three devices indicate a handling issue possibly occurred where a bending force was applied the handle, causing the sheath / basket coil to bend near the handle, causing the observed damage.The provided information stated the issue occurred during use, indicating the devices were functional before the procedure began.All devices are inspected for damage and functionality during manufacturing and quality control checks.Based the available evidence, the devices were inadvertently damaged during use.The sheath of the 4.5fr size basket is thicker and less flexible than the smaller size baskets, which may have been a contributing factor to the issue.Per the quality engineering risk assessment, no further action is warranted.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.

Event Description

Correction: it was accidentally reported in section b5 of the previous report that the procedure was performed on a male when it was actually a female.

• 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: 9081930
• MDR Text Key: 158997187
• Report Number: 1820334-2019-02351
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002175204
• UDI-Public: (01)00827002175204(17)220114(10)9442201
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: G17520
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 9442201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 44