MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE 100W; HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES

Model Number	VERSAPULSE POWERSUITE 100W
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.The system was manufactured on 7-dec-2006 and installed at the customer's site on 4-jan-2007.A lumenis service engineer visited the site the day after the reported event, and found that the laser system's display voltage settings were below specification causing the display to go 'blank'.The voltage was re-adjusted to specification.The engineer completed preventative maintenance, cleaned aligned and calibrated system.Replaced water and di filters.Replaced damaged debris shield and the system was returned to the facility in working order.A review of subject device service records revealed that the subject device has had its annual pm calls on time, during which all required actions had been performed.A review of historical product complaints shows that the same malfunction of a display failure has not led to serious injury in the past.Although the device malfunction did not cause or contribute to any change in the patient's condition, it is uncertain if the user facility had to use the alternate device as intervention to prevent permanent damage.In an abundance of caution lumenis is reporting this as an adverse event.According to the gso expert based on the age of the system, "normal break and tear " could have likely played a role in the failure.Therefore, no additional corrective or preventive action is determined necessary.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).
Event or Problem Description
A user facility reported that during a laser procedure in which a lumenis versapulse powersuite 100w laser system was being utilized, the screen went black.Unable to continue with the system, an alternate device was brought in to complete the procedure.The delay was approximately 25 minutes and the procedure completed without incident or complication.No report of patient complications was received, and no report was received alleging the device malfunction caused or contributed to any change in the patient's condition.

• Brand Name: VERSAPULSE POWERSUITE 100W
• Common Device Name: HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 13949352
• Report Number: 3004135191-2022-00011
• Device Sequence Number: 6581065
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: 07290109140551
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: VERSAPULSE POWERSUITE 100W
• Device Catalogue Number: 0638-803-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2006
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown