MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE P20; POWERED LASER SURGICAL INSTRUMENT,, PRODUCT CODE

Model Number	VERSAPULSE P20
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the subject device dhr confirmed that the subject device was manufactured on 31-mar-2015 and installed at the customer's site on (b)(6) 2015.A lumenis service engineer visited the site four(4) days after the reported event and determined the problem to be a faulty footswitch; the footswitch had been replaced.The engineer also found pitted blastshield, adjusted blastshield sense switch, performed a pm as per service manual.After reconfirming its operation, the engineer returned the system to the facility in working order.A review of system risk files identified the risk of device malfunction (b)(4) which has the potential to lead to "inability to complete treatment which may require re-operation".The risk likelihood has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.A review of historical product complaints shows that the same malfunction of a footswitch failure has not led to serious injury in the past.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 as an adverse event.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 (b)(4).
Event or Problem Description
A user facility reported that during a cystolithotripsy procedure in which a lumenis pulse 20h was being utilized, the system stopped working.The physician tried a basket removal and was unsuccessful.They ended up putting in a stent.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 P20
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT,, PRODUCT CODE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9909541
• Report Number: 3004135191-2020-00036
• Device Sequence Number: 19647708
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• 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): 04/01/2020

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 P20
• Device Catalogue Number: GA-0006000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1