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

Model Number	0638-804-01
Medical Device Problem Codes	Smoking (1585); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that smoke was coming from the fiber port.No errors were received.There was no patient involved.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse tested multiple fibers on the console and verified no smoke was observed.However, the fse also found that the fiber nut place showed signs of smoke.Therefor, the reported event was confirmed.There was not enough information to suggest the probable cause for the smoke observed by the customer.Based on the information available, the cause that contributed to the reported smoke event cannot be established.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse tested multiple fibers on the console and verified no smoke was observed.However, the fse also found that the fiber nut place showed signs of smoke.Therefor, the reported event was confirmed.There was not enough information to suggest the probable cause for the smoke observed by the customer.Based on the information available, the cause that contributed to the reported smoke event cannot be established.
Event or Problem Description
It was reported by the customer that smoke was coming from the fiber port during the procedure.No errors were received.Usage of the console was stopped and the procedure was completed using a different laser system.There were no patient complications.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse tested multiple fibers on the console and verified no smoke was observed.However, the fse also found that the fiber nut plate showed signs of smoke.Therefore, the reported event was confirmed.The lens cell assembly and the blast shield optic were replaced.The plungers were positioned and they reran the harness.It is probable that the lens cell assembly and blast shield were damaged resulting in the smoke observed by the customer.Based on the information available, the cause that contributed to the reported smoke event cannot be established.
Event or Problem Description
It was reported by the customer that smoke was coming from the fiber port during the procedure.No errors were received.Usage of the console was stopped and the procedure was completed using a different laser system.There were no patient complications.

• 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; 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: 15338328
• Report Number: 2124215-2022-32553
• Device Sequence Number: 6927456
• Product Code: GEX
• UDI-Device Identifier: 07290109146218
• UDI-Public: 07290109146218
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 0638-804-01
• Device Catalogue Number: 0638-804-01
• Device Lot Number: 0000001134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 02/27/2023
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/23/2022; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown