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

Model Number	0638-803-01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the console key switch was spinning.There was insufficient information about the outcome of the procedure.Information stated, the procedure was not completed, due to this event.This event is being reported for aborted/cancelled procedure, with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
Upon receipt of this key switch at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned product found that this key switch was received in pieces, the contacts were tested and they open and close as designed.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 key switch, the issue was resolved, and the unit was within specification.Therefore, it is likely that the key switch was damaged and the reported allegation was confirmed.Based on analysis and the information available the damaged key switch could have affected the device performance leading to the event experienced by the customer.
Event or Problem Description
It was reported that during preparation, the console key switch was spinning.The procedure was not completed due to this event.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• Brand Name: VERSAPULSE POWERSUITE
• 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: 17199523
• Report Number: 2124215-2023-32986
• Device Sequence Number: 6741906
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: 07290109146195
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 0638-803-01
• Device Catalogue Number: 0638-803-01
• Device Lot Number: 0000000627
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown