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

Model Number	SLIMLINE SIS 200¿ FIBER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the reporter to request additional information which had been provided.According to the complainant "there was a fragment in the kidney which we saw.We used a number of instruments to try and retrieve.We don't believe that the fragment was in kidney or ureter but possible in bladder or ended up in the navigator."; the procedure was completed by use of a new fiber.A search of the complaint database revealed that no similar complaints of "fiber breaks/fractures" exist for the specified lot.A review of system risk files revealed the following three risks of fibers breaking inside body: risk #1 (1003791_g - risk # 8.1.1) 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 (1003791_g - risk # 8.2.1) triggered by "fiber is damaged during shipment" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #3 (1003791_g - risk # 8.3.1) 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.Subject device was returned to the manufacturer for visual inspection on 25-feb-2019.Initial findings revealed that the "fiber broke while firing.Shows signs of burn marks and a break at 10.1 ft from the sma.Attached to the lab laser in service mode which showed 1.5 hours of use.".Lumenis quality assurance had determined 'operational context' to be the root cause of the reported tip break; the complaint is associated with a product that meets the lumenis design & manufacture specification but due to anatomical/procedural factors encountered during the procedure performance was limited.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.34-01-04-00) and per post marketing surveillance procedure (doc no.1005539).
Event or Problem Description
A user facility reported that during a procedure in which a lumenis slimline sis 200 fiber was being utilized , the fiber tip broke in the patient's kidney.No report of patient injury was received, nor was the event reported to have caused or contributed to any change in the patient's condition.It was further reported that the procedure was completed by use of a new fiber.

• Brand Name: SLIMLINE SIS 200 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: 9792140
• Report Number: 3004135191-2020-00017
• Device Sequence Number: 11406394
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: 07290109140223
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 08/11/2023
• Device Model Number: SLIMLINE SIS 200¿ FIBER
• Device Catalogue Number: 0644-010-01
• Device Lot Number: 15900918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1