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

Model Number	0644-016-01
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber identified that the fiber was received in 2 pieces.Fiber body was broken between connector and tip.Visual inspection of the connector did not identify any defects or burn marks.The reported event is confirmed.It is likely that the observed damage was resulted by applying excessive force to the fiber during procedure.The device instructions for use (ifu) instructs to avoid bending the fiber above the maximum bending radius, as it may lead to energy loss and damage to the endoscope.Based on analysis and the information available, the interaction between the user and device, may have caused or contributed to the observed fiber break and reported event, therefore, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that, during a transurethral lithotripsy procedure, the laser light was unable to radiate and an error message displayed indicating to check the debris shield; the burn of the debris shield was confirmed.The procedure was completed after replacing the debris shield and fiber without patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber identified that the fiber was received in 2 pieces.Fiber body was broken between connector and tip.Visual inspection of the connector did not identify any defects or burn marks.The reported event is confirmed.It is likely that the observed damage was resulted by applying excessive force to the fiber during procedure.The device instructions for use (ifu) instructs to avoid bending the fiber above the maximum bending radius, as it may lead to energy loss and damage to the endoscope.Based on analysis and the information available, the interaction between the user and device, may have caused or contributed to the observed fiber break and reported event, therefore, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that during transurethral lithotripsy (tul) procedure, the laser light was unable to radiate and an error message displayed indicating to check the debris shield.Reportedly, the burn of the debris shield was confirmed.The procedure was completed after replacing the debris shield and fiber without patient complications.Analysis of the returned fiber identified fiber break.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHT GUIDE OPTICS INTERNATIONAL; celtniecibas street 8; livani LV531 6; LG LV5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15869434
• Report Number: 2124215-2022-47802
• Device Sequence Number: 6793522
• Product Code: GEX
• UDI-Device Identifier: 17290109140190
• UDI-Public: 17290109140190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0081551121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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
• Patient Sex: Unknown