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

Model Number	0642-395-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the fiber was connected, it broke when the physician stepped on the pedal.No patient injuries were reported.
Event or Problem Description
It was reported that after the fiber was connected, it broke when the physician stepped on the pedal.The procedure was completed with another fiber.There were no patient complications.
Event or Problem Description
It was reported that after the fiber was connected, it broke when the physician stepped on the pedal.The procedure was completed with another fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.A partial piece of the fiber was returned.Visual examination identified that the distal area of the fiber with the exposed glass tip was not received.The fiber body was observed to be broken.The fiber connector did not exhibit any defects.The fiber was functionally tested and the aiming beam was observed at the break location.With all the available information, boston scientific concludes that the reported observation of fiber break was confirmed as visual examination identified the fiber body to be broken.It is probable that the procedural handling of the device during set-up, may have contributed to the fiber break.Based on these observations, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that after the fiber was connected, it broke when the physician stepped on the pedal.The procedure was completed with another fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.A partial piece of the fiber was returned.Visual examination identified that the distal area of the fiber with the exposed glass tip was not received.The fiber body was observed to be broken.The fiber connector did not exhibit any defects.The fiber was functionally tested and the aiming beam was observed at the break location.With all the available information, boston scientific concludes that the reported observation of fiber break was confirmed as visual examination identified the fiber body to be broken.It is probable that the procedural handling of the device during set-up, may have contributed to the fiber break.Based on these observations, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that after the fiber was connected, it broke when the physician stepped on the pedal.The procedure was completed with another fiber.There were no patient complications.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15628668
• Report Number: 2124215-2022-42165
• Device Sequence Number: 14155489
• Product Code: GEX
• UDI-Device Identifier: 17290109140183
• UDI-Public: 17290109140183
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 08/31/2024
• Device Model Number: 0642-395-01
• Device Catalogue Number: 0642-395-01
• Device Lot Number: 0044641019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 11/16/2022; 01/26/2023; 09/21/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/07/2022; 12/08/2022; 02/17/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown