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

Model Number	0644-016-01
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 fiber tips broke during this ureteroscopy (urs) procedure for kidney stones performed with the console at low power.There was no physical break of the outer layer of any of these 3 fibers.The first fiber tip started to break off and degrade after 30 seconds, the second fiber tip started to break off and degrade after 10 minutes, and the third fiber tip started to break off and degrade after 5 minutes.Then, the physician requested to use a different console.The procedure was completed with an alternate method.There were no patient complications reported.This report corresponds to the second fiber.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified the fiber tip was broken.There was no exposed glass tip.Additionally, burn marks were observed on the fiber jacket.Visual analysis did not exhibit any break along the fiber body.It is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the fiber tip break.In addition, the ifu mentions, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Based on analysis results, the reported broken glass tip was confirmed.
Event or Problem Description
It was reported that 3 fibers were utilized during a kidney stone ureteroscope procedure.During the procedure, the tip of the first fiber broke off, and degraded at low power after 30 second of fiber use.The first fiber was replaced, and during lasing with the second fiber, the tip of the fiber broke off and degraded after 10 minutes of fiber used.The second fiber was replaced, and during lasing with the third fiber, the tip of the fiber also broke off and degraded after 5 minutes of fiber use.The physician then requested a different laser console to complete the procedure.The procedure was completed with another laser without patient complications.This report corresponds to the second fiber.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified the fiber tip was broken.There was no exposed glass tip.Additionally, burn marks were observed on the fiber jacket.Visual analysis did not exhibit any break along the fiber body.It is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the fiber tip break.In addition, the ifu mentions, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Based on analysis results, the reported broken glass tip was confirmed.
Event or Problem Description
It was reported that 3 fibers were utilized during a kidney stone ureteroscope procedure.During the procedure, the tip of the first fiber broke off, and degraded at low power after 30 second of fiber use.The first fiber was replaced, and during lasing with the second fiber, the tip of the fiber broke off and degraded after 10 minutes of fiber used.The second fiber was replaced, and during lasing with the third fiber, the tip of the fiber also broke off and degraded after 5 minutes of fiber use.The physician then requested a different laser console to complete the procedure.The procedure was completed with another laser without patient complications.This report corresponds to the second fiber.

• 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): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16788840
• Report Number: 2124215-2023-18363
• Device Sequence Number: 20253782
• Product Code: GEX
• UDI-Device Identifier: 17290109140190
• UDI-Public: 17290109140190
• 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): 10/02/2023

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: 0008151122
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 09/21/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 08/01/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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