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

Model Number VERSAPULSE P20

Device Problem Failure to Deliver Energy (1211)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the reported event by contacting it's foreign distributor and the user for additional information.Despite reasonable attempts, there was no response from user and no other information was received other than the initial report.The distributer indicated that they have a few hospitals under that umbrella of interior health and therefore they do not know to which hospital the event is related, what system was used and if a complaint was opened for this event in the past.No valid serial number was provided therefore a failure analysis of the complaint device could not be completed.On 23-jan-2013 lumenis issued, a system manufacturing discontinuation note which stated that the technical support will continue till 23-jan-2020.Therefore as of 23-jan-2020, the system is no longer serviceable.A review of system risk files identified the risk of device malfunction (1007141_c - risk # 9.1.1) which has the potential to lead to "inability to complete treatment which may require alternative treatments".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 two-year historical review of similar complaints revealed that system failure during a procedure has not led to serious injury.In this case, the patient was awakened from anesthesia, the procedure was cancelled, 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 to the fda.According to the gso expert based on the age of the system, wear could have likely played a role in the failure.Since this product is no longer manufactured/serviceable, 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 ((b)(4)) and per post marketing surveillance procedure ((b)(4)).

Event Description

Lumenis received a foreign user facility submitted cmdsnet report ((b)(4)) on 7-dec-2021 regarding an event that allegedly happened on the (b)(6) 2021.During a laser lithotripsy and stent exchange procedure in which a lumenis versapulse powersuite 20w laser system was being utilized, error message appeared on the screen "service required".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
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 13116238
• MDR Text Key: 290465083
• Report Number: 3004135191-2021-00086
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSAPULSE P20
• Device Catalogue Number: VPPS20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 81 YR
• Patient Sex: Male