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

Model Number	0644-019-01
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	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the fiber broke.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this slimline sis at our post market quality assurance laboratory, the returned device was thoroughly analyzed.The fiber was received in two pieces; a fiber body break was observed.The microscopic inspection identified that the tip was degraded and there were burn marks on the connector face.When the fiber was connected to the console, the device read: treatment used: 5 treatment left: 5.It is likely 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 which in turn could have led to the connector overheating causing the burn marks.Based on the information available, a conclusion code of caused traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during procedure the fiber broke.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, manufacturer email, g1 mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip, mfr site country, mfr site phone.Upon receipt of this slimline sis at our post market quality assurance laboratory, the returned device was thoroughly analyzed.The fiber was received in two pieces; a fiber body break was observed.The microscopic inspection identified that the tip was degraded and there were burn marks on the connector face.When the fiber was connected to the console, the device read: treatment used: 5 treatment left: 5.It is likely 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 which in turn could have led to the connector overheating causing the burn marks.Based on the information available, a conclusion code of caused traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during procedure the fiber broke.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SLIMLINE SIS 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; hakidma st 6; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17516075
• Report Number: 2124215-2023-43213
• Device Sequence Number: 7943672
• Product Code: GEX
• UDI-Device Identifier: 07290109145587
• UDI-Public: 07290109145587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/03/2023

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 Model Number: 0644-019-01
• Device Catalogue Number: 0644-019-01
• Device Lot Number: 0003860922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/04/2023; 09/21/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/22/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Patient Sex: Unknown