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

Model Number	0644-018-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a photo selective vaporization of the prostate, the fiber broke in the surgeon's hand during use and burnt his finger, the surgeon was attended with first aid.The procedure was completed with another device without patient complications.
Additional Manufacturer Narrative
Mfr email: (b)(6).
Additional Manufacturer Narrative
Correction to field b5.Describe event or problem.Mfr email: (b)(6).
Event or Problem Description
It was reported that during a procedure, the fiber broke in the surgeon's hand during use and burnt his finger, the surgeon was attended with first aid.The procedure was completed with another device without patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the reported fiber break event could not be confirmed, as the fiber was not returned for analysis.Without a returned device, product analysis could not be performed.The device was not returned for analysis; therefore, technical analysis could not be performed.A review of the device history record confirmed that the fiber met manufacturing specification prior to release.Based on the information available, a conclusion code cause not established was assigned to this investigation.Correction to field b5.Describe event or problem.Mfr email: (b)(4).
Event or Problem Description
It was reported that during a laser lithotripsy procedure to remove stone fragments, the fiber broke in the surgeon's hand during use and burnt his finger, the surgeon was attended with first aid.The procedure was completed with another device without patient complications.

• Brand Name: SLIMLINE SIS 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: 17909619
• Report Number: 2124215-2023-55800
• Device Sequence Number: 6653289
• Product Code: GEX
• UDI-Device Identifier: 17290109147038
• UDI-Public: 17290109147038
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/24/2023

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: 0644-018-01
• Device Catalogue Number: 0644-018-01
• Device Lot Number: 0099150722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 10/23/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/23/2023; 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown