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

Model Number	0638-804-01
Medical Device Problem Codes	Defective Device (2588); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was having an ureteroscopy procedure to remove a kidney stone utilizing a holmium laser console.An error message appeared on the laser console screen indicating there was a footswitch connection problem.The surgical technician and nurse restarted the laser console.In addition, the footswitch cord was disconnected from and reconnected to the laser console, but the error messaged persisted.The physician was unable to activate the laser.The footswitch cord then fell off from the laser console connecting receptacle and breaking into 3 pieces.The physician was unable to complete the procedure and placed a ureteral stent to allow the kidney to drain.The physician informed the patient that she would need to return for a second procedure to remove the stone.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15537902
• Report Number: 2124215-2022-39324
• Device Sequence Number: 6037173
• Product Code: GEX
• UDI-Device Identifier: 07290109146218
• UDI-Public: 07290109146218
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 0638-804-01
• Device Catalogue Number: 0638-804-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White