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

Catalog Number	HLF-S365-H30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the cook® single-use holmium laser fiber broke into two pieces (approximately in the middle) after connecting to the laser machine during a rigid ureteroscopy and a ureteral lithotripsy procedure.The procedure was complete with a new same-like device.The device was not inspected for damage prior to use.The aiming beam appeared clear and rounded/oval prior to use.During the procedure, the power setting were set to energy/pulse (j/p) 0.5j, repetition rate (hz) 12hz, total energy (j) 6w.It was reported that manipulation that may have caused damage to the fiber did not occur.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and 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.E1: customer address = postal code: (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.
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, unchanged, or unavailable.Event description: as reported, the 'cook single-use holmium laser fiber' broke into two pieces (approximately in the middle) after connecting to the laser machine during a rigid ureteroscopy and a ureteral lithotripsy procedure.The procedure was complete with a new same-like device.The device was not inspected for damage prior to use.The aiming beam appeared clear and rounded/oval prior to use.During the procedure, the power setting were set to energy/pulse (j/p) 0.5j, repetition rate (hz) 12hz, total energy (j) 6w.It was reported that manipulation that may have caused damage to the fiber did not occur.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu), and quality control procedures.One 'cook single-use holmium laser fiber' was returned in an opened labelled package.The fiber was broken 98.3cm from the distal tip.The distal tip is undamaged.No other damage was noted.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 device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either 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 instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: 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.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 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.A definitive cause of the event could not be determined from the available information.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 19146140
• Report Number: 1820334-2024-00554
• Device Sequence Number: 12752610
• Product Code: GEX
• UDI-Device Identifier: 00827002235526
• UDI-Public: (01)00827002235526(17)261019(10)15717056
• 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
• Report Date (Section B): 07/17/2024

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 Catalogue Number: HLF-S365-H30
• Device Lot Number: 15717056
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: HL-30C
• Patient Sex: Unknown