MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE 60W; POWERED LASER SURGICAL INSTRUMENT

Model Number VERSAPULSE POWERSUITE 60W

Device Problem Failure to Deliver Energy (1211)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

Lumenis received a foreign user facility submitted cfda report (b)(4),on (b)(6) 2022 regarding an event that allegedly happened on the (b)(6) 2022.During a laser lithotripsy for kidney stone procedure in which a lumenis versapulse powersuite 60w laser system was being utilized, "the output power of the laser cannot be adjusted during the procedure, resulting in the failure to achieve the expected therapeutic effect".Unable to continue with the system an alternate device was brought in to complete the procedure.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.

Manufacturer Narrative

Lumenis investigated the reported event.The foreign facility had reported that during a laser lithotripsy for kidney stone procedure in which a lumenis versapulse powersuite 60w laser system was being utilized, the system stopped working.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 (b)(6) 2018 and installed at the customers site on (b)(6) 2020.A lumenis service engineer visited the site one (1) day after the reported event and examined the laser system.The engineer found first 45 mirror damaged and replaced it, adjusted the three-way optical path, cleaned the optical fiber hole and lens.Performed energy check and after verifying that the system is working within manufacturer specifications the system was returned to the facility safe and ready for use.A review of historical product complaints from the past two years shows that the same malfunction of mirror failure has not led to serious injury.To date lumenis is unaware of such events ever having led to injury.A review of system risk files (doc (b)(4) rev c) revealed risk #2.13; system failure which has the potential to lead to prolonged procedure -or- ineffective treatment which may require re-operation.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.The last preventive maintenance was done on (b)(6) 2021 while the event happened on (b)(6) 2022.A review of subject labeling, (0637-117-01 rev.R versapulse powersuite op manual) revealed in the annual laser maintenance "preventative maintenance, safety, power, and calibration checks should be performed annually by a lumenis-certified service engineer to ensure proper laser performance" according to the gso expert this event could have been avoided if the preventive maintenance was done on time.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 malfunction to the fda.Unrelated to the event, lumenis has initiated capa (b)(4) to further investigate various optical issues with the holmium product family lasers.This complaint is being closed to capa (b)(4), and therefore follow-up mdr is not required.Lumenis 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: VERSAPULSE POWERSUITE 60W
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 15109552
• MDR Text Key: 304127068
• Report Number: 3004135191-2022-00019
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: 07290109140575
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSAPULSE POWERSUITE 60W
• Device Catalogue Number: 0638-804-00CN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1