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

Model Number	G25294
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) # - k133788.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 about to do a retrograde intrarenal surgery (rirs) procedure in the kidney.When opening the laser fiber it had a "crack" 50 cm before the red connection.They did not use this device.The procedure was completed using a new fiber.There were no adverse effects to the patient due to this occurrence.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection 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, and quality control data.The complainant returned one open package containing a holmium laser fiber (rpn hlf-s273-hsma), reported lot number confirmed.Visual examination confirmed a partial fiber was returned, 61cm of the proximal end of fiber was received, segment included the plug.The distal fiber segment was not returned.There was no visible damage evident on the plug assembly.The point of separation shows signs of charring with the cladding melted and pulled to separation.There was no visible fiber optics material from the end of cladding.A review of the device history record revealed one non-conformance related to the reported failure.The device was scrapped, removed from the lot and 100% inspection confirmed there were no other non-conformances.A review of complaint records for this lot revealed no other related complaints.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions a number of different factors affect the life of any fiber, including: improper handling.Never subject fiber optics to sharp bends in handling, use or storage.Discard any fiberoptic assembly that is cracked or broken or does not meet minimum transmission standards.Fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.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.Based on the evidence presented, investigation conclusion could not be determined and any of the precautions listed in the ifu could contribute to this event.The complaint is confirmed based on device analysis and customer testimony.Per the quality engineering risk assessment, no additional risk mitigating activity is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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® 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: 8616667
• Report Number: 1820334-2019-01124
• Device Sequence Number: 3236168
• Product Code: GEX
• UDI-Device Identifier: 00827002252943
• UDI-Public: (01)00827002252943(17)210521(10)8897037
• Combination Product (Y/N): N
• 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): 07/12/2019

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: 05/21/2021
• Device Model Number: G25294
• Device Catalogue Number: HLF-S273-HSMA
• Device Lot Number: 8897037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1