MAUDE Adverse Event Report: COOK INC COOK® MULTI-USE HOLMIUM LASER FIBER; GEX LASER INSTRUMENT, SURGICAL

Model Number	G23668
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: asc director.The complaint device has been returned to the manufacturer but the physical investigation is currently underway.The evaluation will be included in he follow up report.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, during a ureteroscopy and using a cook multi-use holmium laser fiber, the fiber tip broke off during the case.The fiber was inspected before use and no damage was noted at that time.The procedure was able to be completed successfully.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the alleged malfunction.
Additional Manufacturer Narrative
Event summary: as reported, during a ureteroscopy and using a cook multi-use holmium laser fiber, the fiber tip broke off during the case.The fiber was inspected before use and no damage was noted at that time.The procedure was able to be completed successfully.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the alleged malfunction.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.The complaint device was returned without packaging.The overall length measured within specification.No breaks or cracks were observed in the blue jacket.The clear fiber tip was not visible, and charring was noted at the distal tip.A function test was performed, and the device was determined to be useable.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.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is provided with instructions for use which warn: ¿-the holmium laser fiber is validated only for the cleaning procedure, steam sterilization parameters, and sterrad cycles that are listed below and must be reprocessed by use of one method listed below.-do not bend at sharp angles.If visible light (aiming beam) can be seen leaking from the fiber, fiber failure may result when therapeutic energy is applied as the fiber is deflected beyond the optical limits of total internal reflection.Discard fiber if visible light is observed.-fiber should not be clamped with forceps or other instruments as it could result in fiber damage or breakage.-the device must be thoroughly cleaned and sterilized per the instructions provided in this document before re-use.Ensure the device and all its crevices are completely dry before use.-any deviation(s) to the reprocessing instructions prescribed in this ifu may damage the device and result in a device which has compromised sterility or is not fully reprocessed to relevant standards and guidelines.-the reprocessing instructions provided have been validated as being capable of preparing the laser fiber for re-use.It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and personnel in the processing facility achieves the desired result.This requires validation and routine monitoring of the process.Likewise, any deviation by the processor from instructions provided below should be properly evaluated for effectiveness and potential adverse consequences.¿ the ifu also cautions: ¿- to avoid reducing the life of the fiber, follow these precautions: ¿ do not improperly handle the fiber ¿ do not lase at high power for extended periods of time ¿ do not lase continuously with the fiber tip in contact with the tissue ¿ do not laser with a fiber that has a containment or damaged proximal end ¿ do not subject the fiber to sharp bends during handling, use, or storage - discard any laser fiber that is cracked or broken or does not meet minimum power transmission standards.- do not exceed recommended power limits¿ based on the available information, cook has concluded that the most probable cause of laser fiber separation is related to the improper handling of the laser fiber and any of the precautions listed in the ifu.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK® MULTI-USE HOLMIUM LASER FIBER
• 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: 12623478
• Report Number: 1820334-2021-02317
• Device Sequence Number: 4270394
• Product Code: GEX
• UDI-Device Identifier: 10827002236681
• UDI-Public: (01)10827002236681(17)240311(10)13818298
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K163197
• 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): 12/12/2021

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: 03/11/2024
• Device Model Number: G23668
• Device Catalogue Number: HLF-M273-H30
• Device Lot Number: 13818298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOLMIUN LASER COOK,
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 57 KG