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

Model Number	0642-394-01
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber broke after 2 minutes of firing during the first use.The procedure was completed with this device.There was no patient complication.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the fiber body observed no damage; however, the reported fiber break event was confirmed as analysis identified the fiber tip was cracked and had normal degradation.Also, the fiber connector exhibited burn marks on the face.During functional testing, the aiming beam was dim.A review of the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.It is likely that an expected or random component failure without any design or manufacturing could have contributed to the fiber break.
Event or Problem Description
It was reported that the fiber broke after 2 minutes of firing during the first use.The procedure was completed with this device.There was no patient complication.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the fiber body observed no damage; however, the reported fiber break event was confirmed as analysis identified the fiber tip was cracked and had normal degradation.Also, the fiber connector exhibited burn marks on the face.During functional testing, the aiming beam was dim.A review of the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.It is likely that an expected or random component failure without any design or manufacturing could have contributed to the fiber break.
Event or Problem Description
It was reported that the fiber broke after 2 minutes of firing during the first use.The procedure was completed with this device.There was no patient complication.

• 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: 15712545
• Report Number: 2124215-2022-44749
• Device Sequence Number: 4972960
• Product Code: GEX
• UDI-Device Identifier: 17290109140176
• UDI-Public: 17290109140176
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2023

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: 02/18/2023
• Device Model Number: 0642-394-01
• Device Catalogue Number: 0642-394-01
• Device Lot Number: 0003620318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2022
• Supplement Date Received by Manufacturer: 01/20/2023; 09/21/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 02/16/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2018
• 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
• Patient Sex: Unknown