MAUDE Adverse Event Report: COOK INC LASER URETERAL CATHETER; GEX LASER INSTRUMENT, SURGICAL

Model Number	G17797
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation- urology coordinator.Pma/510(k) #- k181431.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, the tip of a laser ureteral catheter separated from the device as a laser fiber was passed through the device during preparation for a laser nucleation of the prostate.The device did not make patient contact.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, the tip of a laser ureteral catheter separated from the device as a laser fiber was passed through the device during preparation for a laser nucleation of the prostate.The device did not make patient contact.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.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 (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.The complaint device was returned with its product label to cook for investigation.The severed tip was returned in a specimen jar.The catheter had the adapter attached to the hub and the catheter length was 40 centimeters.The severed tip was approximately 2 millimeters.A review of the device history record (dhr) for the reported lot found no related non-conformances.Additionally, a search of the complaint database found no other complaints for the reported lot number.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 device master record review was performed, including a review of manufacturing instructions and quality control procedures.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 instructions for use (ifu) provides the following information to the user related to the reported failure mode: device description.The catheter will accept a laser fiber up to an overall outer diameter of 1000¿m.Precautions avoid bending or kinking the catheter prior to placement.Doing so could damage the integrity of the catheter and result in patient injury.Cook has concluded a cause for the failure cannot be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or Problem Description
No new patient or event information to report since the previous medwatch report was sent.

• Brand Name: LASER URETERAL CATHETER
• Common Device Name: GEX LASER INSTRUMENT, SURGICAL
• 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: 12701607
• Report Number: 1820334-2021-02393
• Device Sequence Number: 11129567
• Product Code: GEX
• UDI-Device Identifier: 00827002177970
• UDI-Public: (01)00827002177970(17)240428(10)13925214
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: G17797
• Device Catalogue Number: 022403-7.1-40
• Device Lot Number: 13925214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male