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

Catalog Number	HLF-S365-HSMA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510k # - k124030.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
It was reported, early in a bladder stone--cystolithotomy procedure, the tip of the cook® single-use holmium laser fiber broke off.As reported, all pieces were removed from patient.As reported the device was stripped down and continued to be used, procedure completed successfully.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
( product inadvertently missed in the initial medwatch report).Conclusion code: cause not established (4315).Investigation ¿ evaluation.A visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, drawings, instructions for use, and specifications.One opened package labeled rpn hlf-s365-hsma with label lot number 8566717 was received.The device was returned without the protective coil and packaging tray.In addition to the laser fiber, a 5fr yellow catheter (70cm long with 50cm ink marks) was returned.The orange flexible tip of the catheter indicates this is a 021305 flexi-tip ureteral catheter.The catheter was returned without identifying lot number information.The laser fiber was returned in one segment measuring 298.7cm in length.The distal end of the fiber had approximately 1mm of quartz protruding from the blue cladding.Under magnification the cladding has a burnt, ragged appearance.A hole located approximately 2-3 mm from the distal end was visualized in the cladding, quartz with a charred appearance is exposed from the hole.Cladding has a melted appearance.The tip of the quartz has jagged edges and a broken appearance.A review of the device history record found no non-conformances that would contribute to the reported failure.A complaint history search revealed this complaint is the only one associated with lot number 8566717.All holmium fibers are tested per manufacturing specification to assure the fiber is recognized and functions properly and to assure no breaks are present along the fiber length and the green output from the end of fiber creates a well-defined circle.Several scenarios could have contributed to the customer's issue which are listed in the instructions for use (ifu), precautions section.A number of different factors affect the life of any particular fiber, including: extended lasing power.Continuous lasing with fiber tip in contact with tissue.Lasing with a contaminated or damaged proximal end.Improper handling.Poor laser beam alignment or focus.Never subject fiber optics to sharp bends in handling, use or storage.Always keep connector end dry and free from contaminates.Discard any fiberoptic assembly that is cracked or broken, or does not meet minimum transmission standards.Do not exceed power limits.The laser fiber was returned and the broken tip of the fiber was confirmed.The returned fiber had a burned, ragged appearance.A conclusion as to the cause for the fiber break could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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.
Event or Problem Description
No new event information has been received since the last report was submitted on (b)(6) 2018.

• 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
• MDR Report Key: 7670421
• Report Number: 1820334-2018-02137
• Device Sequence Number: 2580053
• Product Code: GEX
• UDI-Device Identifier: 00827002252950
• UDI-Public: (01)00827002252950(17)210206(10)8566717
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: 02/06/2021
• Device Catalogue Number: HLF-S365-HSMA
• Device Lot Number: 8566717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK OPEN END CATHETER; LUMENIS LASER MACHINE; COOK OPEN END CATHETER