MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 200 DFL FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	SLIMLINE 200 DFL FIBER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis cannot rule out that the fiber tip had broken off in the patient's anatomy, and in an abundance of caution lumenis is reporting this event.A search of the complaint database revealed that no other complaints exist for the specified lot.A review of system risk files revealed the following three risks of fibers breaking inside body: risk #1 (b)(4) triggered by "user damages fiber external surface during operation" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #2 (b)(4) triggered by "fiber is damaged during shipment" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #3 (b)(4) triggered by "user error (e.G.Excess energy) causes mechanical damage to fiber" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.In each of the aforementioned; the risk has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.No corrective action or remedial actions were deemed necessary.The procedure was completed normally with no harm caused to the patient as a result of this event.Device was discarded by the user and will not be returned for analysis; therefore a failure analysis of the complaint device could not be completed.Should additional relevant details become available; a supplemental report will be submitted.
Event or Problem Description
On 06-feb-2019 lumenis received a user submitted medwatch report (ref: mw5082896) in which the event description reads: during cystoscopy with right-sided stent exchange, laser lithotripsy, and stone basket extraction - laser fiber of distal portion of the fiber became loose.Able to be taken out through penis without any identification of pieces left within the urethra.

• Brand Name: SLIMLINE 200 DFL FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8377937
• Report Number: 3004135191-2019-00024
• Device Sequence Number: 2978329
• Product Code: GEX
• UDI-Device Identifier: 07290109140261
• UDI-Public: 07290109140261
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 01/18/2021
• Device Model Number: SLIMLINE 200 DFL FIBER
• Device Lot Number: 14710818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2019
• Patient Sequence Number: 1