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

Model Number	840-921
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, there was a device malfunction and due to this, the physician got injured.The patient and procedure outcome are unknown.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber identified it was broken in two pieces.The analysis of the fiber also identified there was a bright and round light exiting the connector face, also observed were scratches on the connector face from normal usage.The fiber was functionally tested and the error 67 (fiber expired! connect new fiber and resume operation) was displayed.It is likely that the procedural handling of the device during set-up and use contributed to the fiber body break occurred during the procedure, leading to the reported event.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.
Event or Problem Description
It was reported that during a procedure, there was a device malfunction and due to this, the physician got injured.The patient and procedure outcome are unknown.

• Brand Name: LUMENIS SLIMLINE EZ SIS SINGLE USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18476374
• Report Number: 2124215-2024-00679
• Device Sequence Number: 20434929
• Product Code: GEX
• UDI-Device Identifier: 17290109140206
• UDI-Public: 17290109140206
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 840-921
• Device Catalogue Number: 840-921
• Device Lot Number: 0097460722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown