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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person) : (b)(6).E3- occupation: technical support engineer.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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
It was reported that the green laser light was visible through the blue coating of a cook® multi-use holmium laser fiber.Additional information regarding the event has been requested but is currently unavailable.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
Additional information received 20nov2023.The green light was seen along the entire length of the fiber.The fiber was either not used or only used once.The procedure was complete by changing to another fiber.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary it was reported that the green laser light was visible through the blue coating of a cook® multi-use holmium laser fiber.The green light was seen along the entire length of the fiber.The fiber was either not used or only used once.The procedure was complete by changing to another fiber.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection and functional test of the device, were conducted during the investigation.One laser fiber was returned.The glass tip was missing and the distal tip appeared darkened in color indicating energy leakage.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode a database search identified two other events reported for unrelated failure modes.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_h30m_rev2] ¿h-30 holmium laser fiber (multi-use),¿ provides the following information to the user related to the reported failure mode: warnings ¿ do not bend fiber 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 leakage is observed.¿ 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.Precautions ¿ 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 lase with a fiber that has a contaminated or damaged proximal end.¿ do not operate a laser with poor beam alignment or focus.¿ do not subject the fiber to sharp bends during handling, use, or storage.¿ always keep the proximal connector end dry and free of contaminants.¿ discard any laser fiber that is cracked or broken or does not meet minimum power transmission standards.¿ do not use this laser fiber in the presence of flammable anesthetics or combustible materials.¿ ferrule dust cap should stay attached when fiber is not connected to the laser system.¿ do not exceed recommended power limits.Instructions for use 9.Check the integrity of laser fiber by using visible aiming beam from laser system.Observe visible light profile out of laser fiber tip.The profile should be a well-defined round or oval pattern.If output beam is not round/oval pattern, or visible light leaks from any spot along the length of the fiber shaft, then the fiber core is broken and the fiber should be discarded as hazardous waste.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive cause of the laser fiber breakage could not be determined.Many factors could have contributed to the laser fiber breakage such as device deflection, variation in the material properties, or having an energy applied that exceeds the recommended power limits.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• 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: 17835713
• Report Number: 1820334-2023-01297
• Device Sequence Number: 7409381
• Product Code: GEX
• UDI-Device Identifier: 10827002236681
• UDI-Public: (01)10827002236681(17)260221(10)15235396
• Combination Product (Y/N): N
• PMA/510(K) Number: K163197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2023

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: 02/21/2026
• Device Model Number: N/A
• Device Catalogue Number: HLF-M273-H30
• Device Lot Number: 15235396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 12/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/21/2023; 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK H30 LASER.
• Patient Sex: Unknown