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

Model Number	GA-2003476
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fever (1858); Sepsis (2067)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an error displayed when output was attempted.After fifteen minutes, the procedure resumed and could be successfully completed with the same device.After the procedure, the patient had a fever and developed sepsis.To treat the infection, the patient had to take antibiotics, and hospitalization was extended.
Event or Problem Description
It was reported that an error displayed when output was attempted.After fifteen minutes, the procedure resumed and could be successfully completed with the same device.After the procedure, the patient had a fever and developed sepsis.To treat the infection, the patient had to take antibiotics, and hospitalization was extended.

• Brand Name: LUMENIS LTD.
• 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): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20466543
• Report Number: 2124215-2024-62865
• Device Sequence Number: 7472059
• Product Code: GEX
• UDI-Device Identifier: 07290109145457
• UDI-Public: 07290109145457
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: GA-2003476
• Device Catalogue Number: GA-2003476
• Device Lot Number: 0000001533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/06/2024
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 40 YR
• Patient Sex: Female