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

Catalog Number	HLF-M273-H30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 retrograde intrarenal surgery , when the doctor was using the cook® multi-use holmium laser fiber it broke in the external side of the ureteroscope, they could retrieve the fiber part that had remained inside the ureteroscope.They stripped the fiber and continued the procedure with the same fiber.No adverse events have been reported as a result of the alleged malfunction.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Additional information: d10.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.One used one multi use 273 fiber was returned for investigation bearing lot number 7770060.Visual examination confirmed the fiber was returned in used condition.The fiber length measured 214cm.Cladding at the distal tip is stretched to separation with 2mm of fiber optic protruding from the cladding.Black charring seen on the cladding behind the point of separation.The fiber is secured inside the plug.The plug and ferrule appear undamaged.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 7770060.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 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.Laser fibers are tested during manufacturing processes to assure the fiber is recognized and no failure codes are present.In addition, to assure no breaks are present along the fiber length and the green output from end of fiber creates a well-defined circle.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Any of the listed factors provided in the ifu can cause the alleged malfunction.Based on the information available an investigation conclusion could not be determined.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.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® 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: 8133559
• Report Number: 1820334-2018-03514
• Device Sequence Number: 2056819
• Product Code: GEX
• UDI-Device Identifier: 10827002236681
• UDI-Public: (01)10827002236681(17)200322(10)7770060
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 03/22/2020
• Device Catalogue Number: HLF-M273-H30
• Device Lot Number: 7770060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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: SENSOR WIRE GUIDE, STORZ FLEXIBLE ENDOSCOPE