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.Visual analysis identified that the fiber was received in two pieces.A break at the distal end of the fiber body was observed.It is likely that the procedural handling contributed to the broken fiber.Microscopic inspection of the tip indicated it had normal degradation.During functional testing, the fiber was connected to the console, and the aiming beam was seen exiting the break location was bright and round.Additionally, the console displayed an error message indicating error #67: fiber expired, connect new fiber and resume operation.Therefore, the reported event of the laser light was unable to radiate, and an error message displayed is confirmed.The device history record (dhr) confirmed that the fiber met all material, assembly and performance specifications.According to the device instructions for use (ifu), avoid bending the fiber above the maximum bending radius (refer to specifications section), as it may lead to energy loss and damage to the endoscope.Inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.Based on the analysis results, an investigation conclusion code of cause traced to component failure 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.The procedure was completed after replacing the debris shield and the fiber without patient complications.Analysis of the returned fiber identified fiber body break.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the fiber was received in two pieces.A break at the distal end of the fiber body was observed.It is likely that the procedural handling contributed to the broken fiber.Microscopic inspection of the tip indicated it had normal degradation.During functional testing, the fiber was connected to the console, and the aiming beam was seen exiting the break location was bright and round.Additionally, the console displayed an error message indicating error #67: fiber expired, connect new fiber and resume operation.Therefore, the reported event of the laser light was unable to radiate, and an error message displayed is confirmed.The device history record (dhr) confirmed that the fiber met all material, assembly and performance specifications.According to the device instructions for use (ifu), avoid bending the fiber above the maximum bending radius (refer to specifications section), as it may lead to energy loss and damage to the endoscope.Inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.Based on the analysis results, an investigation conclusion code of cause traced to component failure 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.The procedure was completed after replacing the debris shield and the fiber without patient complications.Analysis of the returned fiber identified fiber body 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 MA LV531 6; LG LV5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16406158
• Report Number: 2124215-2023-07418
• Device Sequence Number: 15055384
• 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): 10/03/2023

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: 01/30/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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