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

Catalog Number	HLF-S940-H30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
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, during a laser stone extraction procedure, the cook® single-use holmium laser fiber snapped in half and another fiber had to be used which worked as intended to complete the procedure.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
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-s940-h30 with label lot number 7648053 was received.The fiber was returned separated into two segments with both pieces inside the protective coil.The protective coil is partially snapped into the packaging tray.The fiber separated 105.8cm from the plug.The length of the distal segment measures 195.2cm with 6.5mm of crystal protruding from the blue cladding.The total length of the returned specimen is 301cm, indicating no pieces of the fiber are missing.Under magnification black charring was observed on the side and end of the cladding at the point of separation.Cladding at this point had a melted appearance and the crystal is cracked and broken.This indicates a possible crack in the crystal causing breakage when energy was transmitted through the fiber.This device is tested to assure the program has recognized the fiber and no failure codes are present.In addition, inspected to assure no breaks are present along the fiber length and the green output from the end of the fiber creates a well-defined circle.The device history record for lot number 7648053 was reviewed and noted there were no non-conformances related to the reported failure.A search of complaint records revealed this is the only complaint associated with complaint lot number 7648053.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.This 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 breakage of the fiber was confirmed.Damage to the fiber could be a result of any of the factors listed above.A definitive cause of damage was not able to be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 7704339
• Report Number: 1820334-2018-02181
• Device Sequence Number: 19015645
• Product Code: GEX
• UDI-Device Identifier: 00827002237353
• UDI-Public: (01)00827002237353(17)200203(10)7648053
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 02/03/2020
• Device Catalogue Number: HLF-S940-H30
• Device Lot Number: 7648053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 115