MAUDE Adverse Event Report: LUMENIS LTD. ACUPULSE 40 WATT; POWERED LASER SURGICAL INSTRUMENT

Model Number ACUPULSE 40 WATT

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2021

Event Type  malfunction  

Event Description

A user facility reported that a lumenis acupulse 40w co2 laser system presented error 66 - scanner communication error, on its display.Unable to proceed with the laser, the procedure was cancelled.No report of injury was received, and no report was received alleging the device malfunction caused or contributed to any change in the patient's condition.

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly for additional information.Despite reasonable attempts, eight (8) by phone and by email, no additional information was provided.The question if the procedure was canceled prior to anesthetizing the patient remained unanswered.A review of the subject device dhr confirmed that the subject device was manufactured on 10-aug-2014 and installed at the customers site on (b)(6) 2014.A lumenis service engineer visited the site twenty three (23) days after the reported event and examined the laser system.The engineer confirmed the issue as reported and replaced the scanner controller board, performed all system calibrations and tests.The device was found to have met lumenis specifications and ready for use.A review of system risk files (rd-1148040 rev t) revealed risk #10.1 " device malfunction" which have the potential to lead to adverse effects of alternative treatments".The risk likelihood has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within full risk assessment.In this case, the procedure was cancelled, though there is no indication that the patient was under anesthesia, in an abundance of caution, lumenis is reporting this malfunction.According to the gso expert based on the age of the system, wear 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)).

• Brand Name: ACUPULSE 40 WATT
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 12695208
• MDR Text Key: 281097973
• Report Number: 3004135191-2021-00066
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140315
• UDI-Public: 07290109140315
• Combination Product (y/n): Y
• PMA/PMN Number: K100415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUPULSE 40 WATT
• Device Catalogue Number: GA-1000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1