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

Model Number	0642-395-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser enucleation of prostate procedure, the fiber broke and the laser punctured the heel of the physician.The heel injury was treated with alcohol to disinfect and a bandage.The procedure was completed with another fiber without patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that reported complaint could not be confirmed, due to the device did not return.The event injury is a known inherent risk of device use as stated in the instructions for use.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.
Event or Problem Description
It was reported that during a holmium laser enucleation of prostate procedure, the fiber broke and the laser punctured the heel of the physician.The heel injury was treated with alcohol to disinfect and a bandage.The procedure was completed with another fiber without patient complications.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19489428
• Report Number: 2124215-2024-33651
• Device Sequence Number: 7165001
• Product Code: GEX
• UDI-Device Identifier: 17290109140183
• UDI-Public: 17290109140183
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0642-395-01
• Device Catalogue Number: 0642-395-01
• Device Lot Number: 0013000823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 08/18/2023
• 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