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	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laser lithotripsy procedure for renal system stones, the fiber broke in the surgeon hand during use and burnt his finger.First aid was applied, and the procedure was complete with another fiber.There were no patient complications.
Event or Problem Description
It was reported that during a laser lithotripsy procedure for renal system stones, the fiber broke in the surgeon hand during use and burnt his finger.First aid was applied, and the procedure was complete with another fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber identified the device was broken in two pieces.A functional testing was performed with a versapulse console, and the error 67 (fiber expired! connect new fiber and resume operation) was displayed.It is likely that procedural handling of the device during set-up and use contributed to the fiber body break.A partial body break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break which in turn led to the physician thumb being burned, leading to the reported event.The reported fiber break is confirmed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on review of all information available and analysis results, the investigation did not identify any abnormality in manufacturing or design from the risk review, conclusion code of cause traced to component failure and known inherent risk was assigned to this investigation.Burns are a known inherent risk of device use as stated in the instructions for use.Correction made to g1 mfr site facility name, mfr site address 1, mfr site address 2, mfr site city, mfr site state, mfr site zip/post code, mfr site country, mfr site phone.

• 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; hakidma st 6; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17932525
• Report Number: 2124215-2023-56672
• Device Sequence Number: 12362606
• 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
• Report Date (Section B): 01/10/2024

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: 0644-018-01
• Device Catalogue Number: 0644-018-01
• Device Lot Number: 0099150722
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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