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

Catalog Number NCT4-017115

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

It was reported, during a ureteroscopy, when the surgeon opened the basket of an ncompass nitinol tipless stone extractor to grasp the stone the extractor "broke." it is unknown how the procedure was completed.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 had been received on 14apr2020 but not added to file until 17apr2020: the user inserted the basket into the flexible ureteroscope, opened basket, and it broke (the hand held handle broke).The 1cm stone was fragmented prior to extraction, and it was located in the kidney.The procedure was completed by using a zero tip basket for stone extraction.

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.It was reported, during a ureteroscopy, when the surgeon opened the basket of an ncompass nitinol tipless stone extractor to grasp the stone the extractor "broke." the user inserted the basket into the flexible ureteroscope, opened basket, and it broke (the hand held handle broke).The 1cm stone was fragmented prior to extraction, and it was located in the kidney.The procedure was completed by using a zero tip basket for stone extraction.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, manufacturing instructions, and quality control data.One device was returned for investigation.Inspection of the returned device noted that the device was returned with the handle in the open position and the basket formation in the closed position.The mlla (male luer lock adapter) ad collet knob were tight and secure.The polyethylene terephthalate tubing (pett) measured 2.8 cm.The support sheath was severed at the nose of the mlla.2.2 cm of the cannulated handle was exposed.The basket sheath was still attached to 4.1 cm of the support sheath.The cannulated handle was bent 5 mm and 2.3 cm from the severed end of the support sheath.Functional testing of the device noted the handle could not actuate the basket formation.Due to the damage to the cannulated handle, the basket formation could not be manually actuated.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 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 returned device was found to have a basket that was closed and could not be opened due to sheath damage.The basket sheath and orange support sheath were both separated near the device handle.The separated sheaths prevented the motion of the handle from opening the basket.The provided information stated the issue occurred during use of the device.Devices are inspected for damage and functionality multiple times during manufacturing and quality control inspections.The device was also packaged with the basket in the open position, indicating the device was not damaged when received by the customer.It is possible that the device was damaged during use due to procedural factors such as the size, shape, or location of the stones, user technique, or interaction with another device such as the scope.There is no information provided related to procedural issues, therefore the definitive cause for the issue could not be determined.Cook could has concluded that a cause for the damage could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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: NCOMPASS NITINOL 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: 9962367
• MDR Text Key: 199993803
• Report Number: 1820334-2020-00824
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002460277
• UDI-Public: (01)10827002460277(17)220703(10)9855729
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Catalogue Number: NCT4-017115
• Device Lot Number: 9855729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXIBLE URETEROSCOPE.
• Patient Age: 47 YR
• Patient Weight: 82