MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE P20; POWERED LASER SURGICAL INSTRUMENT

Model Number	VERSAPULSE POWERSUITE P20
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lumenis certified service engineer visited the site on (b)(6) 2018, two weeks after the reported event and examined the laser system.The engineer found the issue to be with the laser's key-switch.The key switch was replaced and the system was returned to the facility having met manufacturer's specifications.To the best of lumenis' knowledge, the subject device is back in use at the facility.The dhr of the subject device was reviewed and no link was found between the manufacturing process at lumenis and the current event.The system was manufactured, tested and released according to lumenis specifications.The subject device was manufactured on 15-oct-2013.A review of system risk files ((b)(4)) revealed risk #(b)(4); system failure which has the potential to lead to prolonged procedure -or- ineffective treatment which may require re-operation.The risk has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within full risk assessment.The "key switch" has not been returned to the manufacturer for analysis; therefore a failure analysis of the device could not be completed.However, it had been reported by the distributor that the key-switch failure was likely due to "simple wear & tear".A two year historical review of similar complaints revealed that the same malfunction of "key switch" failure prior to or during a procedure has not led to serious injury in the past.To date lumenis is unaware of such events ever having led to injury.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.
Event or Problem Description
Lumenis was informed by a foreign distributor that a foreign user facility reported that prior to the start of a ureteroscopy procedure in which a lumenis versapulse powersuite p20 laser was to be utilized, the operator was unable to start the laser by turning the key switch.An alternate laser, a lumenis pulse 100 was then brought in to the room to continue the procedure.Immediately after turning on the p100 laser, a loud noise was observed and the laser subsequently turned off, leaving the laser inoperable.As there was no other alternate device to complete the procedure, the patient was awakened from anesthesia.No report of injury was received, nor did the malfunction cause or contribute to any change in the patient's status.This is for device 1 or 2 (lumenis versapulse powersuite p20).

• Brand Name: VERSAPULSE POWERSUITE P20
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8266335
• Report Number: 3004135191-2019-00006
• Device Sequence Number: 2035971
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• Combination Product (Y/N): N
• Initial Reporter Country: GP
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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 P20
• Device Catalogue Number: GA-0006000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR