MAUDE Adverse Event Report: LUMENIS LTD VERSACUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0637-245-01
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by a field service engineer who determined that the handpiece needed to be serviced.The damaged handpiece could have affected the device performance leading to the reported clinical observations.
Event or Problem Description
It was reported that, during the procedure, the blade at the end of the handpiece did not rotate.The blade was replaced, and the console was turned restarted, but the issue did not resolve.The procedure was not completed due to reported issue.No patient complications were reported.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.

• Brand Name: VERSACUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17993042
• Report Number: 2124215-2023-58709
• Device Sequence Number: 12582019
• Product Code: GCJ
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2023

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: 0637-245-01
• Device Catalogue Number: 0637-245-01
• Device Lot Number: 0000000060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown