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

Model Number	0642-393-01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, the fiber connector was broken and there was no output energy.There were no patient complications reported.The device was returned, and analysis found a fiber body break.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.The fiber was retuned in two pieces.Microscopic inspection of the tip indicated it had normal degradation.The fiber could not be functionally tested due to the separation; therefore, the aim beam could not be observed.
Event or Problem Description
It was reported that, during procedure, the fiber connector was broken and there was no output energy.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.The fiber was retuned in two pieces.Microscopic inspection of the tip indicated it had normal degradation.The fiber could not be functionally tested due to the separation; therefore, the aim beam could not be observed.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 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: 16378407
• Report Number: 2124215-2023-06688
• Device Sequence Number: 14972899
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/01/2023

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: 08/18/2024
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0043810919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 10/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown