MAUDE Adverse Event Report: LUMENIS LTD ACCU-BEAM FIBEROPTIC HANDPIECE; POWERED LASER SURGICAL INSTRUMENT

Model Number	UNK-P-CO2_ACCESSORIES
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of a procedure, error 74 (scanner position z axis error) was displayed on the console screen.As a result, there was no procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes that the alleged error 74 (scanner position z axis error) that displayed on the console and led to the cancel procedure, is confirmed.Additional information indicated that the facility was still waiting for approval to purchase a new scanner component.Based on this information, it is probable that the scanner component is damaged and requires replacement.In addition, the console device history record confirmed that it met manufacturing specifications prior to release, and the service history showed that the console was functional until the date of the reported event.Therefore, it is highly unlikely that the cause of the reported event is related to manufacturing but the scanner component.Section d: suspect medical device corrected to reflect co2 accessory section g: corrected to reflect manufacturing site.Correction: detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the completed udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during preparation of a procedure, error 74 (scanner position z axis error) was displayed on the console screen.As a result, there was no procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Event or Problem Description
It was reported that during preparation of a procedure, error 74 (scanner position z axis error) was displayed on the console screen.As a result, there was no procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes that the alleged error 74 (scanner position z axis error) that displayed on the console and led to the cancel procedure, is confirmed.Additional information indicated that the facility was still waiting for approval to purchase a new scanner component.Based on this information, it is probable that the scanner component is damaged and requires replacement.In addition, the console device history record confirmed that it met manufacturing specifications prior to release, and the service history showed that the console was functional until the date of the reported event.Therefore, it is highly unlikely that the cause of the reported event is related to manufacturing but the scanner component.Section d: suspect medical device corrected to reflect co2 accessory.Section g: corrected to reflect manufacturing site.

• Brand Name: ACCU-BEAM FIBEROPTIC HANDPIECE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21495953
• Report Number: 2124215-2025-12414
• Device Sequence Number: 20825155
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: 07290109140308
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/18/2025

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: UNK-P-CO2_ACCESSORIES
• Device Catalogue Number: UNK-P-CO2_ACCESSORIES
• Device Lot Number: 0000003148
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 05/22/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 06/16/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACUPULSE CONSOLE; ACUPULSE CONSOLE
• Patient Sex: Unknown