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

Model Number SLIMLINE SIS 200¿ FIBER

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2020

Event Type  malfunction  

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 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
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9792140
• MDR Text Key: 277884860
• Report Number: 3004135191-2020-00017
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: 07290109140223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1