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

Model Number	UNK-P-MICROMANIPULATORS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the acuspot mirror fell out.The procedure could not be completed due to this event.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 an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Event or Problem Description
It was reported that during a procedure, the acuspot mirror fell out.The procedure could not be completed due to this event.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 an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
A work order was performed, a dichroic mirror was replaced and an alignment of the acuspot was performed this was added over fully functional and without restrictions.After the field service engineer replaced the dichroic mirror, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the available information, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that during a procedure, the acuspot mirror fell out.The procedure could not be completed due to this event.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 an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
A work order was performed; a dichroic mirror was replaced and an alignment of the acuspot was performed this was added over fully functional and without restrictions.After the field service engineer replaced the dichroic mirror, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Based on the available information, the investigation conclusion code selected for this complaint is cause traced to component failure.Correction: block d1 and d4 was corrected with the micromanipulator information.Block d4:h4 the event was unable to provide the upn/lot number of the micromanipulator.Therefore, there is not information related with device manufacturer day.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.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.

• Brand Name: ACUSPOT
• 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 ind. park; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21588936
• Report Number: 2124215-2025-14714
• Device Sequence Number: 8832884
• Product Code: GEX
• UDI-Device Identifier: 07290109140308
• UDI-Public: 07290109140308
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180597
• 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,Followup
• Report Date (Section B): 07/17/2025

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-MICROMANIPULATORS
• Device Catalogue Number: UNK-P-MICROMANIPULATORS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 07/07/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/25/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown