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

Catalog Number NTSE-045065-UDH

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Customer name and address= phone: (b)(6).Pma/510(k) number = 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, two sealed ncircle tipless stone extractor packages leaked air, and "bubbles" were noted in the sterile packages.The packages reportedly looked normal upon receipt to the hospital from the distribution facility and the storage environment "met requirement".The devices did not make patient contact, and there has been no impact to any patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction- b1, h1: there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.Furthermore, there is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.Two unopened devices were returned.Visual exam noted poly portion of package appears crinkled and wrinkled.The device history record for the reported complaint device lot records no non-conformances.A lot history search found no other complaints have been reported for this lot.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Two devices were returned in unopened pouches.The clear mylar material of both pouches were wrinkled in appearance, leading to concerns about the sterility of the devices.The likely cause for the deformation is that the pouches were exposed to high heat, humidity, or both.Possibly over a prolonged period.The user supplied several pictures of the hospital storage area.The storage area appears to be a normal part of the building and not any type of basement or other sub-optimal storage area that would indicate the issue occurred due to storage conditions.All pouches are inspected by quality control after manufacturing for defects.The packages were very likely damaged during the shipping process.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

No new patient or event information since the last report was submitted.

• 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: 12383843
• MDR Text Key: 268691154
• Report Number: 1820334-2021-02077
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002175201
• UDI-Public: (01)10827002175201(17)230728(10)13332339
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 13332339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Date Manufacturer Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1