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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of historical product complaints from the past two years shows that the same malfunction of the display has not led to serious injury.A review of system risk files found the risk of system failure ((b)(4)) which has the potential to lead to ineffective treatment which may require prolonged operation or re-operation.The risk has been quantified and found to be remote, and the risk likelihood 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.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.A review of the subject device dhr confirmed that the subject device was manufactured on 2005.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)).
Event or Problem Description
A user facility reported that during a ureteroscopy procedure in which a lumenis versapulse powersuite 100w laser was being utilized, the displayed turned black.Unable to complete the procedure, the patient was awakened from general anesthesia and the case needed to be 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: 10974239
• Report Number: 3004135191-2020-00089
• Device Sequence Number: 19642133
• 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
• 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): 12/09/2020

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: 11/14/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1