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

Model Number	0638-800-01
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, after the patient was sedated, the console was shutting down on its own.An error message was prompted stating "all lasers malfunctioning, contact service." the console was restarted and error 801 was prompted.A fiber was connected to the console, however, the same error occurred.The error messages couldn't be cleared to continue use.The procedure was not completed due to this event.This event is being reported for procedure aborted after patient sedation.
Additional Manufacturer Narrative
Manufacturer's email address: (b)(4).
Additional Manufacturer Narrative
The service repair was performed by the field service engineer.During service repair, the field service engineer (fse) replaced high voltage power supply (hvps) and central processing unit (cpu) board.Fse performed extensive troubleshooting.A new cpu board and pump motor were ordered.A new cpu board cleared error 801 code.Fse replaced bricks 1 and 4.Alignment was performed on bricks 1 and 4.It was observed that brick 3 was calibrating at very high values and was determined that brick 3 will need replacement.New pump motor was replaced with manifold and flow switch was also replaced.According to the information provided, even though the product analysis states that the component was in good condition, after the fse changed the cpu, the issue was resolved, and the unit was within specification.Therefore, it is likely that the cpu was damaged.Therefore, the reported allegation is confirmed.Additional to this, as no reported allegations, the pump motor, the bricks, the manifold, the flow switch, the second relay mirror and the hvps were replaced, these components are not related to the issue experienced by the customer.Based on the analysis results, the investigation conclusion code of cause traced to component failure was assigned to this investigation.Manufacturer's email address: (b)(4).
Event or Problem Description
It was reported that during a procedure, after the patient was sedated, the console was shutting down on its own.An error message was prompted stating "all lasers malfunctioning, contact service." the console was restarted and error 801 was prompted.A fiber was connected to the console, however, the same error occurred.The error messages couldn't be cleared to continue use.The procedure was not completed due to this event.This event is being reported for procedure aborted after patient sedation.
Additional Manufacturer Narrative
The service repair was performed by the field service engineer.During service repair, the field service engineer (fse) replaced high voltage power supply (hvps) and central processing unit (cpu) board.Fse performed extensive troubleshooting.A new cpu board and pump motor were ordered.A new cpu board cleared error 801 code.Fse replaced bricks 1 and 4.Alignment was performed on bricks 1 and 4.It was observed that brick 3 was calibrating at very high values and was determined that brick 3 will need replacement.New pump motor was replaced with manifold and flow switch was also replaced.According to the information provided, even though the product analysis states that the component was in good condition, after the fse changed the cpu, the issue was resolved, and the unit was within specification.Therefore, it is likely that the cpu was damaged.Therefore, the reported allegation is confirmed.Additional to this, as no reported allegations, the pump motor, the bricks, the manifold, the flow switch, the second relay mirror and the hvps were replaced, these components are not related to the issue experienced by the customer.The returned device was visually inspected and the water pump, water pump manifold, and the cpu with the eeprom boards were found in good physician condition.According to the information provided, even though the product analysis states that the component was in good condition, after the field service engineer changed the cpu, the water pump, the flow switch and the relay mirror, the issue was resolved, and the unit was within specification.Therefore, it is likely that the cpu and water pump were damaged.Therefore, the reported allegation is confirmed.Additional to this, as no reported allegations, the pump motor, the bricks, the manifold, the flow switch, the second relay mirror and the hvps were replaced, these components are not related to the issue experienced by the customer.Based on the analysis results, the investigation conclusion code of cause traced to component failure was assigned to this investigation.Manufacturer's email address: (b)(6).
Event or Problem Description
It was reported that during a procedure, after the patient was sedated, the console was shutting down on its own.An error message was prompted stating "all lasers malfunctioning, contact service." the console was restarted and error 801 was prompted.A fiber was connected to the console, however, the same error occurred.The error messages couldn't be cleared to continue use.The procedure was not completed due to this event.This event is being reported for procedure aborted after patient sedation.
Event or Problem Description
It was reported that during a procedure, after the patient was sedated, the console was shutting down on its own.An error message was prompted stating "all lasers malfunctioning, contact service." the console was restarted and error 801 was prompted.A fiber was connected to the console, however, the same error occurred.The error messages couldn't be cleared to continue use.The procedure was not completed due to this event.This event is being reported for procedure aborted after patient sedation.
Additional Manufacturer Narrative
The service repair was performed by the field service engineer.During service repair, the field service engineer (fse) replaced high voltage power supply (hvps) and central processing unit (cpu) board.Fse performed extensive troubleshooting.A new cpu board and pump motor were ordered.A new cpu board cleared error 801 code.Fse replaced bricks 1 and 4.Alignment was performed on bricks 1 and 4.It was observed that brick 3 was calibrating at very high values and was determined that brick 3 will need replacement.New pump motor was replaced with manifold and flow switch was also replaced.According to the information provided, even though the product analysis states that the component was in good condition, after the fse changed the cpu, the issue was resolved, and the unit was within specification.Therefore, it is likely that the cpu was damaged.Therefore, the reported allegation is confirmed.Additional to this, as no reported allegations, the pump motor, the bricks, the manifold, the flow switch, the second relay mirror and the hvps were replaced, these components are not related to the issue experienced by the customer.The returned device was visually inspected and the water pump, water pump manifold, and the cpu with the eeprom boards were found in good physician condition.According to the information provided, even though the product analysis states that the component was in good condition, after the field service engineer changed the cpu, the water pump, the flow switch and the relay mirror, the issue was resolved, and the unit was within specification.Therefore, it is likely that the cpu and water pump were damaged.Therefore, the reported allegation is confirmed.Additional to this, as no reported allegations, the pump motor, the bricks, the manifold, the flow switch, the second relay mirror and the hvps were replaced, these components are not related to the issue experienced by the customer.Based on the analysis results, the investigation conclusion code of cause traced to component failure was assigned to this investigation.Manufacturer's email address: (b)(4).

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17653458
• Report Number: 2124215-2023-43578
• Device Sequence Number: 12333669
• Product Code: GEX
• UDI-Device Identifier: 07290109146164
• UDI-Public: 07290109146164
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/05/2024

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: 0638-800-01
• Device Catalogue Number: 0638-800-01
• Device Lot Number: 0000000430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 10/31/2023; 03/14/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/28/2023; 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown