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

Model Number	AC-2003592
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3.Manufacturer email: (b)(6).
Event or Problem Description
It was reported that the suction tube for the procedure was worn out by the heat of the roller pump, causing the tube to cut.The suction tube was cracked, and powder was coming out, and the suction was not working properly.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Event or Problem Description
It was reported that the suction tube for the procedure was worn out by the heat of the roller pump, causing the tube to cut.The suction tube was cracked, and powder was coming out, and the suction was not working properly.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
Upon receipt of this device at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified scuff marks on the surface of the tube.It is likely that the scuff marks were caused by the interaction between the tube and the pump.It is probable that the tube could have been placed incorrectly on the pump, which could have lead the heating of the pump, causing the damage to the suction tube.Instructions for use (ifu) state: do not use tubing other than that provided by lumenis.Using alternative tubing may jeopardize the safe operation of the instrument.Aspiration tubing is only qualified for single use and may not be resterilized.Discard after use.Insert the sterile aspiration tubing into the pump head, as shown.Leave sufficient tubing at the right-hand side to reach the tissue catch while allowing for maximum tubing to the handpiece.Ensure that the tubing is seated securely within the pump head, on top of the metal rollers and under the black side clamps.Aspiration flows in the direction of the arrow on the pump head.Always verify that the aspiration tube is loaded in the required direction.Use the lowest effective aspiration rate until you are comfortable and proficient with the instrument.

• Brand Name: VERSACUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17362144
• Report Number: 2124215-2023-37964
• Device Sequence Number: 12279026
• Product Code: GCJ
• UDI-Device Identifier: 07290109140629
• UDI-Public: 07290109140629
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: AC-2003592
• Device Catalogue Number: AC-2003592
• Device Lot Number: B00020323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2023
• 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