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

Catalog Number NFHSES-032115-3W-UDH

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation = unknown.Pma/510k # ¿ exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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

As reported, after opening the package of an nforce nitinol helical stone extractor, it was discovered that the metal wire at the front end of the sheath at the handle was broken.The issue with this device was discovered prior to making contact with the patient and it was not used.Another same type device was used to completed the procedure.There was no impact to the patient.

Manufacturer Narrative

Event summary: as reported, after opening the package of an nforce nitinol helical stone extractor, it was discovered that the metal wire at the front end of the sheath at the handle was broken.The issue with this device was discovered prior to making contact with the patient and it was not used.Another same type device was used to completed the procedure.There was no impact to the patient.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.The device was returned without package or label for investigation.Some rough surface area was noted near the support tubing.When the handle was actuated, the basket would not open or close.The device was disassembled, and the basket sheath and support sheath were no longer secured together.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿precaution: do not use excessive force to manipulate this device.Damage to the device may occur.¿ based on the available information, cook has concluded that it is likely the basket sheath was initially damaged, which prevented the basket assembly from moving freely within the basket sheath, then the increased force between those two components caused the basket sheath and support sheath to separate.The cause for the damage was unknown.Excessive force may have been inadvertently applied to the device, but no information was known regarding device handling.Therefore, the cause of the issue could not be conclusively determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NFORCE NITINOL HELICAL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14775203
• MDR Text Key: 303236340
• Report Number: 1820334-2022-01101
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002179407
• UDI-Public: (01)10827002179407(17)241221(10)14433394
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: 14433394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1