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	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, they were getting ready to do laser lithotripsy, the cook® single-use holmium laser fiber was inserted into the scope and they noticed the tip of the fiber was cracked.The cracked fiber did not make patient contact.A new fiber was used to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Additional information: concomitant medical products.(b)(4).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, instructions for use, manufacturing instructions, quality control data, specifications, and trends.One opened package labeled rpn hlf-s365-h30 with label lot number 8628926 was received.The device was received inside the protective coil and returned without the packaging tray.Upon receipt, it was noted the proximal end of the device was protruding from the coil.Dimensional verification confirmed length of the returned device measured 300.1cm.Visual examination of the returned device was performed.The fiber optics is protruding 6mm from the blue polymer cladding on the distal tip.During microscopic magnification, clear inner lining is observed extending beyond the blue cladding.There is 2mm of fiber optics extending above the lining.When examined the lining was pulled away from the fiber optic using tweezers.During the examination of the fiber tip, the optics broke 3mm below the distal tip of the cladding.Further examination revealed the distal edge has been chipped.No additional damage or manufacturing anomalies were noted on the device.This device is tested to assure the program has recognized the fiber and no failure codes are present.In addition, it is inspected to assure no breaks are present along the fiber length and the green output from the end of fiber creates a well-defined circle.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.The device history record was reviewed and noted there were no non-conformances that may have contributed to this incident.A search of complaint records revealed this is the only complaint associated with complaint lot number 8628926.The instructions for use (ifu) advises that 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 complaint is confirmed based on the device analysis.From the provided information, an investigation conclusion is not able to be established, however, it is likely that damage occurred during handling.The complaint is confirmed based on the device analysis.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
There has been no new information received since the last report was submitted.

• 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: 7889216
• Report Number: 1820334-2018-02710
• Device Sequence Number: 2365273
• Product Code: GEX
• UDI-Device Identifier: 00827002235526
• UDI-Public: (01)00827002235526(17)210227(10)8628926
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 02/27/2021
• Device Catalogue Number: HLF-S365-H30
• Device Lot Number: 8628926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1