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

Model Number AC-2003592

Device Problems Defective Device (2588); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

D3.Manufacturer email: (b)(6).

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 319428481
• Report Number: 2124215-2023-37964
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07290109140629
• UDI-Public: 07290109140629
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2023
• 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