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

Catalog Number NTSE-022115-UDH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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 the ncircle tipless stone extractor basket was deformed upon opening the package.An alternative like device was used to complete the procedure was intended.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Evaluation / investigation a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation is in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2.6 cm.A functional test noted the handle actuated the basket formation.A visual examination noted the support sheath is severed in two places: one at the nose of the mlla and measures 11 mm in length, the other segment measures 3.2 cm.The first segment is adhered to the basket sheath and a 5-mm section of the basket sheath is exposed between the hub segment and the first segment, both are adhered to the basket sheath and appear to be mating.The second segment is detached from the basket sheath and mates to segment one.A review of the device history record found no non-conformance's related to the reported failure.A review of complaint history for this device lot revealed this complaint is the only one associated with lot number 8245849.As found in the instructions for use (ifu) precaution section: enclose the device in the sheath before removing from the tray/holder.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.It was reported that the basket of the device was deformed.Visual observation found that the sheath of the device had damage.The sheath damage prevented the basket from fully opening.The observed damage likely occurred during handling/use of the device.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.H3 other text : blank fields on this form indicate the information is unknown, unchanged, or unavailable.Evaluation / investigation a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation is in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2.6 cm.A functional test noted the handle actuated the basket formation.A visual examination noted the support sheath is severed in two places: one at the nose of the mlla and measures 11 mm in length, the other segment measures 3.2 cm.The first segment is adhered to the basket sheath and a 5-mm section of the basket sheath is exposed between the hub segment and the first segment, both are adhered to the basket sheath and appear to be mating.The second segment is detached from the basket sheath and mates to segment one.A review of the device history record found no non-conformances related to the reported failure.A review of complaint history for this device lot revealed this complaint is the only one associated with lot number 8245849.As found in the instructions for use (ifu) precaution section: enclose the device in the sheath before removing from the tray/holder.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.It was reported that the basket of the device was deformed.Visual observation found that the sheath of the device had damage.The sheath damage prevented the basket from fully opening.The observed damage likely occurred during handling/use of the device.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: 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: 7369347
• MDR Text Key: 103459368
• Report Number: 1820334-2018-00796
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200926(10)8245849
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1