MAUDE Adverse Event Report: COOK INC COOK® SINGLE-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	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person): postal code: (b)(6) // phone: (b)(6).E3- occupation: nurse manager, area manager.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 when a cook® single-use holmium laser fiber was connected to the laser machine, "there were sparks coming out of the connector prior to firing the laser fibre".The procedure was completed using another laser fiber.It should be noted that additional information was received stating that there was no energy being provided to the fiber.It appears that the blue end attached to the red connector is burnt.It was thought by the product representative that the fiber was not connected properly to the laser machine causing the spark.The laser machine has worked fine with other laser fibers since this occurrence.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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
Event summary it was reported that when a cook® single-use holmium laser fiber was connected to the laser machine, "there were sparks coming out of the connector prior to firing the laser fibre".The procedure was completed using another laser fiber.It should be noted that additional information was received stating that there was no energy being provided to the fiber.It appears that the blue end attached to the red connector is burnt.It was thought by the product representative that the fiber was not connected properly to the laser machine causing the spark.The laser machine has worked fine with other laser fibers since this occurrence.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 of the returned device, were conducted during the investigation.One device was returned in opened packaging.The handle and fiber were returned separated.At the point of separation, where fiber meets the hub, the coating has a darkened appearance.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 the recorded non-conformances of ¿component detached, fiber¿ relevant to the failure mode where two devices were scrapped.A complaint lot search found one other complaint for broken laser fiber shaft reported by the same customer.Because adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and only one other lot related complaint has been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The product ifu, [t_h30s_rev1] ¿h-30 holmium laser fiber (single-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.¿ fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.Precautions ¿ 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.How supplied upon removal from package, inspect the product to ensure no damage has occurred.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.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® 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: 17767588
• Report Number: 1820334-2023-01252
• Device Sequence Number: 7192982
• Product Code: GEX
• UDI-Device Identifier: 00827002235533
• UDI-Public: (01)00827002235533(17)260504(10)15423606
• Combination Product (Y/N): N
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 05/04/2026
• Device Model Number: N/A
• Device Catalogue Number: HLF-S273-H30
• Device Lot Number: 15423606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYSTOSCOPE, UNKNOWN MFR.; FLEXIBLE URETEROSCOPE, UNKNOWN MFR.; FLEXOR ACCESS SHEATH.; GUIDEWIRE, UNKNOWN MFR.; URETERIC CATHETER, UNKNOWN MFR.
• Patient Sex: Unknown