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

Model Number	0644-020-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Burn(s) (1757); Electric Shock (2554)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fiber broke during the procedure and touched the physician's arm, who felt an electric shock since it was activating the laser.The physician did not receive any treatment for the electric shock.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Corrected content in fields h6 patient codes and impact codes, section h.Device manufacturers only.
Event or Problem Description
It was reported that the fiber broke during the procedure and touched the physician's arm, who felt an electric shock since it was activating the laser and suffered a burn.The physician did not receive any treatment for the burn.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the fiber glass body was broken given the length in which it was received.The fiber tip end was not returned.Functional testing indicated that the aiming beam was bright and round.The reported allegation was confirmed.It is likely that procedural conditions of the device during set-up or use contributed to the fiber body break.A fiber could be damaged or kinked during setup and fully break once laser energy is applied thus leading to what the physician experienced.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.The reported patient symptoms are a known risk associated with these devices as indicated in the instructions for use.
Event or Problem Description
It was reported that the fiber broke during the procedure and touched the physician's arm, who felt an electric shock since it was activating the laser and suffered a burn.The physician did not receive any treatment for the burn.The procedure was completed with another device.There were no patient complications.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23037391
• Report Number: 2124215-2025-61711
• Device Sequence Number: 9455482
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: (01)17290109145669(11)241123(17)291023(10)21841124
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

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: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0021841124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 10/27/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/29/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2024
• 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