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

Catalog Number	HLF-M365-H30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical devices: h30 holmium laser 30 watt, nephroscope, and access sheath.(b)(6).Pma/510k # k124030.(b)(4).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, during a percutaneous nephrolithotomy (pcnl) procedure, yellow sparks started to appear between the end of the cook® multi-use holmium laser fiber and the stone and from the side part of the stripped area of the fiber.The aiming beam disappears or became very poor, and the stone doesn't react during the lasing.The doctor stopped the procedure and replaced the fiber with a new one.After investigation with microscope our service engineer saw dark burned surface on the contact point on the fiber connector.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Investigation/evaluation: a visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and trends.The customer returned one open package labeled part number hlf-m550-h30 with lot number 7629468 for investigation.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.The overall length of the fiber measured 300.4cm which is within specification.No additional damage or manufacturing anomalies were noted on the device.The instructions for use (ifu) lists precautions that state several different factors affect the life of any 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.A review of the device history record shows there were no non-conformances associated with the complaint device lot number that would have caused or contributed to this event.A review of complaint history records revealed this complaint to be the only one associated with complaint lot number 7629468.Laser fibers are tested during the manufacturing process.Testing assures the fiber is recognized and no failure codes are present.In addition, assures no breaks are present along the fiber length and green output from end of fiber creates a well-defined circle.A review of relevant manufacturing documents was conducted.It was concluded that the device was functionally inspected by quality control and no notable gaps in production or processing controls were noted.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Furthermore, a search of complaint records found this is the only complaint associated with lot 7629468.The laser fiber was returned, and fiber damage was confirmed.From the provided information and technical evaluation of the returned fiber, the investigation conclusion determined cause as improper handling of the fiber.Per the quality engineering risk assessment, no further risk mitigating activity is required.The appropriate internal 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.
Event or Problem Description
Additional information received on 27dec2018: the customer refurbishes fibers at their facility using solution for fast sterilization.The fiber used in this event had not been sterilized; the reported issue occurred on the first case.The fiber had been used zero times.

• 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: 8141230
• Report Number: 1820334-2018-03385
• Device Sequence Number: 1439374
• Product Code: GEX
• UDI-Device Identifier: 10827002236667
• UDI-Public: (01)10827002236667(17)200127(10)7629468
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 01/27/2020
• Device Catalogue Number: HLF-M365-H30
• Device Lot Number: 7629468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR