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 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the subject device dhr confirmed that the subject device was manufactured on 28-dec-2011 and installed at the customer's site on (b)(6) 2012.The user facility did not request service for the system but rather ordered a new footswitch.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 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 the same malfunction of a footswitch failure 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.In this case, an alternate laser was brought in to complete the case with no complications to the patient.Although the device malfunction did not cause or contribute to any change in the patient's condition, it is uncertain if the user facility had to use the alternate device as intervention to prevent permanent damage.In an abundance of caution, lumenis is reporting this malfunction.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 Description

A user facility reported that during a lithotripsy procedure, in which a lumenis versapulse p20 laser system was being utilized, the footswitch of the system failed and the system was unable to fire.Unable to proceed with the laser, the procedure was successfully completed with an alternate device.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 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 11153309
• MDR Text Key: 256431550
• Report Number: 3004135191-2021-00002
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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: 0641-000-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2011
• 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