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	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility to obtain additional information regarding the alleged "unit stopped functioning during a case"; partial additional information was provided.A lumenis service engineer visited the site three (3) days after the reported event and examined the device.The user facility reported about an "intermittent shutdown" and the engineer was unable to duplicate any errors under normal operation.The engineer verified alignment, performed power check.All power within specifications.The device was found to have met lumenis specifications and ready for use.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 22-may-2007 and installed at the customer's site on 7-jun-2007.A review of system risk files found the risk of system failure (1007143_b - risk # 2.13) which has the potential to lead to ineffective treatment which may require prolonged operation or 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.In this case the patient was awakened from anesthesia, the procedure was cancelled and rescheduled though from the service engineer findings it looks like the user facility could have restarted the system and continue with the operation.Although there was no report of injury associated with this event, lumenis believes that subjecting a patient to another round of anesthesia carries inherent risks, and in an abundance of caution, lumenis is reporting this event.Since the service engineer was unable to duplicate the alleged malfunction, the root cause of the failure could not be established.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop ((b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).
Event or Problem Description
A user facility reported that during a cysto right retrograde procedure with right stent placement on a 26-wk pregnant female, in which a lumenis versapulse powersuite 100 w laser was being utilized, the system displayed error message and stopped working.Unable to complete the procedure, the patient was awakened from general anesthesia and rescheduled.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 ; IS 20692
• MDR Report Key: 10429923
• Report Number: 3004135191-2020-00058
• Device Sequence Number: 2171143
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: 07290109140551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 08/04/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1