MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS EZ; POWERED LASER SURGICAL INSTRUMENT

Model Number 0644-016-01

Device Problem Break (1069)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that during preparation, the fiber was plugged into machine but not it was not used.When the customer came back to clean it up, it was noticed that the fiber had snapped in 3 places.Another fiber was used to perform the procedure.No patient complications were reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The device instructions for use (ifu) instructs that it is important to ensure the fiber is properly handled so that it is not damaged by being stepped on, pulled, left lying in a vulnerable position, kinked or tightly coiled.The information received from customer stated that the fiber was not damaged upon unpacking.Based on the information provided, it is likely the interaction between the user and the fiber during set up could have caused the reported allegations.

Event Description

It was reported that during preparation, the fiber was plugged into machine but not it was not used.When the customer came back to clean it up, it was noticed that the fiber had snapped in 3 places.Another fiber was used to perform the procedure.No patient complications were reported.

• Brand Name: SLIMLINE SIS EZ
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHT GUIDE OPTICS INTERNATIONAL LTD; celtniecibas str 8; hakidma st 6; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18966342
• MDR Text Key: 338600012
• Report Number: 2124215-2024-17622
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: 17290109147045
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170121
• 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: 05/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0088440322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1