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

Model Number	G23553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a flexible ureteroscopy in the kidney with stent insertion, a cook® single-use holmium laser fiber broke.A cook flexor access sheath was placed over a cook hiwire® nitinol core wire guide, and the inner dilator and wire were removed.Another manufacturer's flexible scope was prepared, and the laser fiber was removed from the packaging.A sharp bend was noticed in the laser fiber approximately one centimeter into the blue coating at the tip's end.The fiber was inserted into the laser unit, and the aiming beam was turned on and read the fiber.The fiber shone at the sharp bend, indicating the fiber was broken.The fiber was removed, and another fiber of the same lot was used to complete the procedure successfully.The faulty laser fiber did not make patient contact.A section of the device did not remain inside the patients body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.
Additional Manufacturer Narrative
Customer (person) - phone: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Event summary: as reported, during a flexible ureteroscopy in the kidney with stent insertion, a cook® single-use holmium laser fiber broke.A cook flexor access sheath was placed over a cook hiwire® nitinol core wire guide, and the inner dilator and wire were removed.Another manufacturer's flexible scope was prepared, and the laser fiber was removed from the packaging.A sharp bend was noticed in the laser fiber approximately one centimeter into the blue coating at the tip's end.The fiber was inserted into the laser unit, and the aiming beam was turned on and read the fiber.The fiber shone at the sharp bend, indicating the fiber was broken.The fiber was removed, and another fiber of the same lot was used to complete the procedure successfully.The faulty laser fiber did not make patient contact.A section of the device did not remain inside the patients body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.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), the instructions for use, manufacturing instructions, and quality control data.A device failure analysis was conducted on the returned product: the device was returned in open packaging.The tip of fiber was broken approx.1.2cm from tip of clear tip.A review of the device history record (dhr) found one non-conformances related to the reported failure mode.A review of complaint history records shows two 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: warnings do not attempt to reprocess.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 available information, it could not be determined if the product was damaged prior to distribution or during the advancement through the scope.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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 ; 8128294891
• MDR Report Key: 13543249
• Report Number: 1820334-2022-00237
• Device Sequence Number: 3734528
• Product Code: GEX
• UDI-Device Identifier: 00827002235533
• UDI-Public: (01)00827002235533(17)240331(10)13861889
• 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): 03/29/2022

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: 03/31/2024
• Device Model Number: G23553
• Device Catalogue Number: HLF-S273-H30
• Device Lot Number: 13861889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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: STORZ FLEX X2 URETEROSCOPE
• Patient Sex: Female