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

Catalog Number NTSE-022115-UDH

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

Name and address: postal code: (b)(6).Occupation: quality coordinator.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

As reported, during an unspecified procedure, when opening the package of an ncircle tipless stone extractor, the doctor identified that the device was damaged.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.Additional information has been requested regarding the event.At the time of this report, no further information has been provided.

Event Description

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

Manufacturer Narrative

Event summary: as reported, during an unspecified procedure, when opening the package of an ncircle tipless stone extractor, the doctor identified that the device was damaged.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.No photos were provided.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 the field.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of relevant manufacturing and quality control documents was conducted.All extractors are inspected for damage and verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: the device is conductive.Avoid contact with any electrified instrument.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 complaint device was not returned.The nature and cause of the reported damage could not be determined.For the purpose of completing the complaint investigation, it was assumed the damage would have prevented the basket from opening or closing.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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 14162472
• MDR Text Key: 289898298
• Report Number: 1820334-2022-00622
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)240617(10)14033069
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 14033069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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