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

Model Number	G23553
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after inserting a cook single-use holmium laser fiber into a laser machine, the aiming beam of the laser exited through the side of the laser fiber approximately 20cm from the distal tip, indicating a potential breakage in the laser fiber.The device did not make patient contact.Another laser fiber was used to successfully complete the procedure.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
Blank fields on this form indicate the information is unknown or unavailable.Name and address- phone: (b)(6).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.
Additional Manufacturer Narrative
Event summary: as reported, after inserting a cook single-use holmium laser fiber into a laser machine, the aiming beam of the laser exited through the side of the laser fiber approximately 20cm from the distal tip, indicating a potential breakage in the laser fiber.The device did not make patient contact.Another laser fiber was used to successfully complete the procedure.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, manufacturing instructions and quality control procedures, as well as a visual inspection were conducted during the investigation.The device was returned in opened packaging and with the packaging tray for investigation.The fiber blue jacket was broken and torn (but still partially connected by the jacket material) at approximately 17 cm from the distal tip.The clear distal tip was intact and approximately 6mm in length.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.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.Cook laser fibers are 100% inspected to assure no breaks are present along the fiber length.Review of the manufacturing specifications, product work order, complaint history, and lot nonconformances suggested the product was built to specification.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The device is provided with instructions for use which caution, ¿a number of different factors affect the life of any particular fiber, including: extended lasing at high power, continuous lasing with the fiber tip in contact with tissue, lasing with a contaminated or damaged proximal end, improper handling, poor laser beam alignment or focus, never subject fiberoptics to sharp bends in handling, use, or storage.Always keep connector-end dry and free from contaminants.Discard any fiberoptic assembly that is cracked or broken, or does not meet minimum transmission standards.Do not exceed recommended power limits.¿ the device is provided with instructions for use which state, ¿how supplied: upon removal from the package, inspect the product to ensure no damage has occurred." the ifu also warns, ¿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.¿ since there was no report of damage upon removal of the device from the packaging, and no manufacturing issues, cook has concluded that it is most likely the device was unintendedly damaged during the procedural preparation.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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® SINGLE-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: 15794353
• Report Number: 1820334-2022-01724
• Device Sequence Number: 17341201
• Product Code: GEX
• UDI-Device Identifier: 00827002235533
• UDI-Public: (01)00827002235533(17)250803(10)14875087
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 08/03/2025
• Device Model Number: G23553
• Device Catalogue Number: HLF-S273-H30
• Device Lot Number: 14875087
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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: Unknown