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

Model Number	GA-0000070
Medical Device Problem Codes	Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the vocal cord polypectomy surgery, the console reported error 74 (scanner positioning error); after restarting according to the prompts, the device could not be turned on and used, which affects the surgical process.During the operation, the laser cutting of vocal cord polyps was temporarily changed to enucleation, which increases the difficulty of the operation for doctors due to the patient's wound became larger.The procedure was completed with different device.There was no patient complication.
Additional Manufacturer Narrative
Correction to field f10: patient codes.Correction to field h6: patient codes.
Event or Problem Description
It was reported that during the vocal cord polypectomy surgery, the console reported error 74 (scanner positioning error); after restarting according to the prompts, the device could not be turned on and used, which affects the surgical process.During the operation, the laser cutting of vocal cord polyps was temporarily changed to enucleation, which increases the difficulty of the operation for doctors due to the patient's wound became larger.The procedure was completed with different device.There was no patient complication.

• Brand Name: ACUPULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 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: 21197435
• Report Number: 2124215-2025-01412
• Device Sequence Number: 7544751
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: 07290109140308
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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-0000070
• Device Catalogue Number: GA-0000070
• 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: 12/25/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/21/2025
• Date Device Manufactured: 03/09/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female