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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 510k: k124030.The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
The customer stated that during a urology case, a laser was being used and while lasing a 5 mm stone in the ureteropelvic junction (upj) on the right side with a 200 micron fiber, a small piece of the fiber tip broke off into the patient.It was reported to be approximately around 2 mm.It was reported that the physician searched for the tip and feels it either came out with the sheath or the patient will void it due to its small size.There were no additional procedures performed, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, instructions for use (ifu), specifications and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: precautions: a number of different factors affect the life of any particular fiber, including: extended lasing at high power.Continuous lasing with the 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 contaminants.Discard any fiber optic assembly that is cracked or broken, or does not meet minimum transmission standards.Do not exceed recommended power limits.The visual inspection of the returned device reported the one open package was received.Fiber length from distal tip to silicone hub cover measured 290.7cm, 1mm of fiber optics was protruding from the blue cladding.When illuminated, no visible cracks could be seen during investigation.Under magnification, several scrape marks were visible on the cladding starting 10cm -12cm, 42cm between 47-48cm and lastly between 133-133.5cm from distal tip.Slight charring was visible at the distal end on the cladding and the fiber.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6521680
• Report Number: 1820334-2017-00719
• Device Sequence Number: 734428
• Product Code: GEX
• UDI-Device Identifier: 00827002237339
• UDI-Public: (01)00827002237339(17)191219(10)7531377
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HLF-S200-H30
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention