MAUDE Adverse Event Report: COOK INC FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS; FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY

Model Number G56431

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2021

Event Type  Injury  

Event Description

As reported, during a stone extraction procedure, a metal substance came out of the lumen of the sheath in a flexor parallel ureteral access sheath and dilators set.The device was used for insertion of another manufacturer's scope, a laser, and a cook ncircle basket.When using the basket for stone extraction, two metal substances were observed among the stones.These substances were removed from the patient using the basket.The procedure was completed with the flexor sheath.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Event summary as reported, during a stone extraction procedure, a metal substance came out of the lumen of the sheath in a flexor parallel ureteral access sheath and dilators set.The device was used for insertion of another manufacturer's scope, a laser, and a cook ncircle basket.When using the basket for stone extraction, two metal substances were observed among the stones.These substances were removed from the patient using the basket.The procedure was completed with the flexor sheath.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned for investigation in open packaging.Both the sheath and dilator assemblies were returned.There was no damage visible to either assembly.Two small black fragments were also returned.After examining the fragments under magnification, it was verified that the reported ¿metal substance¿ was plastic, likely from the sheath, and not metal.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿prior to placement, activate the hydrophilic coating by removing the dilator from the flexor sheath and immersing all components in sterile water or isotonic saline.This will allow the hydrophilic surface to absorb water and become lubricious, easing placement under standard conditions.¿ based on the available information, cook has concluded that while the damage that caused the observed fragments may have been the result of interaction with the devices inserted through the sheath during the procedure, there was not enough evidence to conclusively determine a cause for this event.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

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

Manufacturer Narrative

An additional evaluation of the returned complaint device was conducted.The sheath was split open along its length and no damage to the inner diameter was noted.The dilator and sheath were visually inspected and no missing sections of either component was found.It is likely the two fragments reported by the user did not come from the fus device.The information provided stated that a cook ncircle basket was also used in the procedure.The fragments could not have come from the basket as the size, shape, and material of the fragments do not match any part of a basket device.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

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

• Brand Name: FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
• Type of Device: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• 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 ; 8123392235
• MDR Report Key: 12803675
• MDR Text Key: 280699134
• Report Number: 1820334-2021-02490
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00827002564312
• UDI-Public: (01)00827002564312(17)230304(10)13027813
• Combination Product (y/n): N
• PMA/PMN Number: K172217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: G56431
• Device Catalogue Number: FUS-095045-P
• Device Lot Number: 13027813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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
• Treatment: BOSTON SCIENTIFIC VERAPULSE LASER; COOK NCIRCLE 1.5FR BASKET; OLYMPUS P7 SCOPE
• Patient Outcome(s): Required Intervention