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

Catalog Number NTSE-045065-UDH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2018

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 during preoperative testing, the basket on a ncompass nitinol tipless stone extractor was unable to open and close.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

Investigation ¿ evaluation.A visual inspection and functional testing of the returned devices was conducted.A document based investigation was also conducted.A review of complaint history, the device history record, quality control data, and specifications was performed.Device a: the device was returned with the handle in the open position.The basket formation is in the open position.The collet knob is tight and secure.The male lure lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) was not returned.There were no kinks noted in the basket sheath.A functional test determined the handle actuated the basket formation to the open and closed position, but drag is noted.The width of the basket formation 1.5 cm and the length is 2.5 cm.Device b: the device was returned with the handle in the open position.The basket formation is in the open position.The collet knob is tight and secure.The mlla is loose.There were no kinks noted in the basket sheath.A visual examination noted the basket formation is flattened in appearance.A functional test noted the handle actuated the basket formation.The basket formation was noted to drag slightly.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of the device history record showed no non-conformances associated to the complaint device lot number.A complaint history search revealed this complaint is the only one associated with the complaint device lot number 8190327.Per 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 devices would not function.Device a: the handle actuated the basket formation to the open and closed position, but drag was noted.The cause for the observed drag was not determined.Device b: a functional test noted the handle actuated the basket formation.The basket formation was noted to drag slightly.Deformation of the basket was also observed.The cause for the observed drag or basket deformation was not determined.Per the quality engineering risk assessment, no further action is required.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.Investigation ¿ evaluation.A visual inspection and functional testing of the returned devices was conducted.A document based investigation was also conducted.A review of complaint history, the device history record, quality control data, and specifications was performed.Device a: the device was returned with the handle in the open position.The basket formation is in the open position.The collet knob is tight and secure.The male lure lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) was not returned.There were no kinks noted in the basket sheath.A functional test determined the handle actuated the basket formation to the open and closed position, but drag is noted.The width of the basket formation 1.5 cm and the length is 2.5 cm.Device b: the device was returned with the handle in the open position.The basket formation is in the open position.The collet knob is tight and secure.The mlla is loose.There were no kinks noted in the basket sheath.A visual examination noted the basket formation is flattened in appearance.A functional test noted the handle actuated the basket formation.The basket formation was noted to drag slightly.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of the device history record showed no non-conformances associated to the complaint device lot number.A complaint history search revealed this complaint is the only one associated with the complaint device lot number 8190327.Per 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 devices would not function.Device a: the handle actuated the basket formation to the open and closed position, but drag was noted.The cause for the observed drag was not determined.Device b: a functional test noted the handle actuated the basket formation.The basket formation was noted to drag slightly.Deformation of the basket was also observed.The cause for the observed drag or basket deformation was not determined.Per the quality engineering risk assessment, no further action is required.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: 7376946
• MDR Text Key: 103796182
• Report Number: 1820334-2018-00818
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002175204
• UDI-Public: (01)00827002175204(17)200901(10)8190327
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-045065-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1