MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS EZ; POWERED LASER SURGICAL INSTRUMENT

Model Number	0644-016-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during ureteroscopy, the fiber broke in the physician hand and caused a burn to the right thumb.There were no clinical consequences to the patient.Boston scientific has been unable to obtain additional information regarding the procedure outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that during ureteroscopy, the fiber broke in the physician's hand and caused a burn to the right thumb.There were no clinical consequences to the patient.Boston scientific has been unable to obtain additional information regarding the procedure outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received in two pieces.A fiber break was observed along the fiber body.Based on the analysis results the reported event is confirmed.It is probable that procedural handling of the device during set-up and use contributed to the fiber body break.A partial body break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break and in turn led to the burn on the physician hand.The instructions for use (ifu) state to inspect the fiber for kinks, punctures, or other damage.If the fiber appears damaged, do not use the device, return it to the supplier for replacement.Hold the fiber tip to a non-reflective surface and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.Improper use of the fiber or use of a damaged fiber may result in severe eye or tissue damage, or fire in the treatment room, or accidental laser exposure to the treatment room personnel or patient.Based on available information and analysis results, an investigation conclusion code of cause traced to component failure was assigned to this investigation which indicates and expected or random component failure without any design or manufacturing issue.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The fiber was received in two pieces.A fiber break was observed along the fiber body.Based on the analysis results the reported event is confirmed.It is probable that procedural handling of the device during set-up and use contributed to the fiber body break.A partial body break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break and in turn led to the burn on the physician hand.The instructions for use (ifu) state to inspect the fiber for kinks, punctures, or other damage.If the fiber appears damaged, do not use the device, return it to the supplier for replacement.Hold the fiber tip to a non-reflective surface and ensure that a circular red/green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.Improper use of the fiber or use of a damaged fiber may result in severe eye or tissue damage, or fire in the treatment room, or accidental laser exposure to the treatment room personnel or patient.Based on available information and analysis results, an investigation conclusion code of cause traced to component failure was assigned to this investigation which indicates and expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during ureteroscopy, the fiber broke in the physician's hand and caused a burn to the right thumb.There were no clinical consequences to the patient.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani MA LV-53 16; LG LV-5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16550116
• Report Number: 2124215-2023-12299
• Device Sequence Number: 17640671
• Product Code: GEX
• UDI-Device Identifier: 17290109140190
• UDI-Public: 17290109140190
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0005871022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 09/21/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 07/18/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown