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

Model Number	G23668
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: phone: (b)(6).Occupation: cook sales representative.Event description: it was initially reported, two cook® multi-use holmium laser fibers were damaged after disinfection.During a flexible ureteroscopy, the doctor noticed that the fibers present many "rifts" the "rifts" were located on the laser fiber bodies.The issue with the devices was discovered prior to making contact with the patient and they were not used.The devices were returned to the manufacturer and evaluation of the returned devices on 25feb2021 determined both fibers were separated.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient 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 data.One open package containing two holmium laser fibers was returned for investigation.Device a: the total length of the laser fiber measured 210cm, indicating approximately 90cm of the laser fiber was separated.There were several places on the laser surface that were damaged and signs of melting was observed at the point of separation.Device b: the total length of laser fiber measured as 251cm, indicating that approximately 49cm of laser fiber was separated.No kinks were observed along the returned segment.Charring was visible at the distal end of laser fiber and at the point of separation.A review of relevant manufacturing documents was conducted.The device is inspected visually and functionally for cracks and fractures by manufacturing and quality control and no notable gaps in production or processing controls were noted.A review of the device history record found no non-conformance's related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions several different factors affect the life of any fiber, including: 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.Poor reprocessing (length of fiber removed in reprocessing should be no less than 2.5 cm).Lasing with a contaminated or damaged proximal end.Improper handling.Poor laser beam alignment or focus.Never subject fiber to sharp bends in 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.Ferrule dust cap should stay attached when the fiber is not connected to the laser system.Do not exceed recommended power limits.Sterilization: note: ensure that the device is completely dry before sterilization by looking for moisture deposition on the surfaces of the device.Sterilization should be performed in accordance with industry standards and with a validated sterilization cycle.Store and handle reprocessed fiber assemblies with the same care as similar new devices, following all previously mentioned warnings, notes, and precautions.3place the appropriately packaged device (see packaging section above) into an iso/aami (b)(4) compliant moist heat sterilization system (steam sterilizer) or a validated sterrad system.Select any one of the sterilization cycles indicated and explain for stream sterilization and sterrad sterilization.Warnings: all personnel present in the laser hazard zone must wear all suggested protective devices.Wear laser safety eyewear per the laser manufacturer's specifications.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 of the methods listed below.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.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 below 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 the instructions provided below should be properly evaluated for effectiveness and potential adverse consequences.Inspection of the returned devices found the laser fibers were broken and melting signs were observed on both laser fibers.Close examination of the point of separation of one of fibers showed black charring which indicates separation occurred while laser energy was transmitted through the fiber, indicating the fiber was used.Cook has concluded that based on evidence presented, the most probable cause of laser fiber separation is related to improper handling and reprocessing of the laser fiber may have contributed to laser fiber separation.Laser fiber instruction for use (ifu) contains detailed instruction for laser fiber handling and reprocessing.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.We will continue to monitor for similar complaints.
Event or Problem Description
It was initially reported, two cook® multi-use holmium laser fibers were damaged after disinfection.During a flexible ureteroscopy, the doctor noticed that the fibers present many "rifts" the "rifts" were located on the laser fiber bodies.The issue with the devices was discovered prior to making contact with the patient and they were not used.The devices were returned to the manufacturer and evaluation of the returned devices on 25feb2021 determined both fibers were separated.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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
• MDR Report Key: 11514572
• Report Number: 1820334-2021-00965
• Device Sequence Number: 3625120
• Product Code: GEX
• UDI-Device Identifier: 10827002236681
• UDI-Public: (01)10827002236681(17)221031(10)10122092
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 10/31/2022
• Device Model Number: G23668
• Device Catalogue Number: HLF-M273-H30
• Device Lot Number: 10122092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1