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

Model Number AC-10030210

Device Problem Break (1069)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the fiber fractured after a sound.The procedure was completed with another device.There were no patient complications.

Event Description

It was reported that the fiber fractured after a sound.The procedure was completed with another device.There were no patient complications.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified a fiber body break near the connector.Inspection of the fiber tip indicted it was degraded to the fiber jacket.The connector was in good condition.The fiber was functionally tested.Functional test identified that the aiming beam is bright and distorted.Based on analysis results, procedural handling of the device during set-up and use may have contributed to the fiber break.A conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: SLIMLINE SIS EZ
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• 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; yonkneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19051835
• MDR Text Key: 340457536
• Report Number: 2124215-2024-20095
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2024

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: AC-10030210
• Device Catalogue Number: AC-10030210
• Device Lot Number: 0077040721
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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