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

Model Number	RG0638-803-00
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endoscopic ureteroscopy and insertion of stent procedure, when the fiber was inserted into the console, it switched off.It was tried to use another fiber and also tried another fiber from a different lot number, but the console shut down in both attempts.The patient was under general anesthesia but there were no patient complications reported.The procedure was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console, and the low voltage power supply was replaced.The replacement resolved the issue reported; therefore, the complaint was confirmed.After that, the console was working as intended.Based on review of all information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during an endoscopic ureteroscopy and insertion of stent procedure, when the fiber was inserted into the console, it switched off.It was tried to use another fiber and also tried another fiber from a different lot number, but the console shut down in both attempts.The patient was under general anesthesia but there were no patient complications reported.The procedure was cancelled.Additionally, it was informed that the fibers used during the procedure were not bsc product.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
As of today, the above referenced laser console has not been returned; therefore, no physical or visual analysis of the laser console could be performed.However, the console was serviced onsite by a field service engineer (fse).The fse performed a physical inspection of the console, and the low voltage power supply was replaced.The replacement resolved the issue reported; therefore, the complaint was confirmed.After that, the console was working as intended.Based on review of all information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during an endoscopic ureteroscopy and insertion of stent procedure, when the fiber was inserted into the console, it switched off.It was tried to use another fiber and also tried another fiber from a different lot number, but the console shut down in both attempts.The patient was under general anesthesia but there were no patient complications reported.The procedure was cancelled.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

• 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; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19177273
• Report Number: 2124215-2024-24749
• Device Sequence Number: 6342308
• Product Code: GEX
• UDI-Device Identifier: 07290109145853
• UDI-Public: 07290109145853
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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: RG0638-803-00
• Device Catalogue Number: RG0638-803-00
• Device Lot Number: 0000000040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 08/06/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/05/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown