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

Catalog Number NTSE-022115-UDH

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Occupation- lead tech.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, the tip of a ncircle tipless stone extractor separated while in the patient.Additional patient outcome and event information has been requested.

Manufacturer Narrative

H3: device evaluated by mfg: other (81) - device evaluation has begun; however, a conclusion is not yet available.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

Additional information was received on 17jun2021.The procedure being performed was a ureteroscopy.No unintended section of the device remained inside of the patient's body.The physician removed the broken tip using a three-pronged grasper through a flexible ureteroscope.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, the tip of a ncircle tipless stone extractor separated while in the patient during a ureteroscopy.No unintended section of the device remained inside of the patient's body.The physician removed the broken tip using a three-pronged grasper through a flexible ureteroscope.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.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, and quality control data.The complainant returned one used ncircle tipless stone extractor, ntse-022115-udh, to cook for inspection.The device was returned with the handle in the open position.The basket and support sheaths were severed 1 mm from the handle.The mlla (male luer lock adapter) was loose, while the collet knob was tight and secure.The polyethylene terephthalate tubing (pett) measured 2.5 cm.One wire in the basket formation was broken, one piece of the wire was missing and not returned.With the handle in the open position, a kink was noted at the cannulated handle and coil junction.2 cm of the cannulated handle was exposed.The support and basket sheaths were still adhered.Kinks were found in the basket sheath 35.8 cm, 60 cm, and 81.2 cm from the distal tip.Functional testing determined that 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 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 the 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 extent of the damage to the returned device indicates the device likely experienced excessive force.There may have been procedural factors that led the user the apply to excessive force to the device, but no information related to procedural factors was provided.The cause for the observed damage could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook 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: 12023855
• MDR Text Key: 258618085
• Report Number: 1820334-2021-01539
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 13890960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention