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

Model Number	0638-803-00
Medical Device Problem Codes	Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console pedal sticks and continues to fire even when the surgeon removes his leg from the pedal.There is also a rattling sound inside the footswitch.There was no patient or procedure involved.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this unit was serviced at the facility by a field service engineer (fse).The fse replaced the foot switch of the console system.Based on the work performed on the console, it is likely that the footswitch was damaged.Based on this information, the reported event is confirmed.The labelling review did not reveal any evidence of device off-label use or failure to follow instructions.The instruction for use (ifu) instructs that to prevent accidental laser discharge, always verify that the laser system is in standby mode before disconnecting the delivery system.Based on the information available, and console analysis results, an evaluation conclusion code of cause traced to component failure was assigned for the component damaged which could have affected the device performance and its integrity leading to the event experienced by the customer.
Event or Problem Description
It was reported that the console pedal sticks and continues to fire even when the surgeon removes his leg from the pedal.There is also a rattling sound inside the footswitch.There was no patient or procedure involved.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15396511
• Report Number: 2124215-2022-35165
• Device Sequence Number: 6198704
• Product Code: GEX
• UDI-Device Identifier: 07290109145853
• UDI-Public: 07290109145853
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 0638-803-00
• Device Catalogue Number: 0638-803-00
• Device Lot Number: 002-47551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown