MAUDE Adverse Event Report: COOK INC OPTILITE 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	03/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The event is currently under investigation.
Event or Problem Description
During a bilateral uretero pyeloscopy, laser and stent exchange on a (b)(6) year old male patient with a normal anatomy, the wire snapped in half during the case.The fiber broke in the distal part of the scope.The scope was removed from within the patient and the broken fiber was simply pulled out of the scope by the surgeon.Another wire was opened and used.No piece of device remained inside patient.The patient did not require an additional procedure.No adverse effect to patient have been reported.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, and visual inspection of the returned device was conducted during the investigation.Visual examination of the returned device confirmed the fiber was separated.The point of separation occurred 83.1cm from the distal tip; length of remaining fiber segment measured 208.8cm.The distal tip of the fiber optics had a cracked appearance and the first 5mm of the fiber sheathing had a charred appearance.The device was forwarded to the supplier for investigation.The supplier investigation states that fiber-optics are made of glass (quartz) and should be handled with care.Sharp bends or excessive pressure will cause cracks and fracture that will make the fiber-optics break or over-heat at the damaged spot.Using metal clamps or any other clamping devices to secure the fiber to the sterile gown or any other manipulations with the fiber not recommended as the metal tools can damage the fiber buffer causing the fiber core to break during surgical procedures.The fiber under examination exhibited cracks along the length consistent with mishandling.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: OPTILITE 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: 5596028
• Report Number: 1820334-2016-00287
• Device Sequence Number: 16239216
• Product Code: GEX
• UDI-Device Identifier: 00827002486140
• UDI-Public: (01)00827002486140(17)181006(10)6209362
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K073496
• 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): 03/30/2016

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 Model Number: N/A
• Device Catalogue Number: HLF-S273-CNV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2016
• Supplement Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR