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

Model Number	0642-393-01
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during soft ureteroscopy lithotripsy, the fiber broke inside the patient.Device was removed from the patient's body and procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
H10: upon receipt of the fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.The fiber was received in one piece.Visual analysis showed that the fiber tip had normal degradation down to the fiber jacket.During functional testing.Light from the connector was distorted due to the degraded tip, but there was no light escaping from the fiber body.Based on this observation, the reported event was not confirmed as fiber did not exhibit any breaks.It is probable that procedural conditions, such as physicians technique, size and composition of the material being ablated, may have contributed to the heavy degradation of the tip.According to the ifu, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber.Since the analysis was unable to confirm a fiber tip break, a conclusion code of no problem detected was assigned to the investigation.
Event or Problem Description
It was reported that during soft ureteroscopy lithotripsy, the fiber broke inside the patient.Device was removed from the patient's body and procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.The fiber was received in one piece.Visual analysis showed that the fiber tip had normal degradation down to the fiber jacket.During functional testing.Light from the connector was distorted due to the degraded tip, but there was no light escaping from the fiber body.Based on this observation, the reported event was not confirmed as fiber did not exhibit any breaks.It is probable that procedural conditions, such as physicians technique, size and composition of the material being ablated, may have contributed to the heavy degradation of the tip.According to the ifu, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber.Since the analysis was unable to confirm a fiber tip break, a conclusion code of no problem detected was assigned to the investigation.
Event or Problem Description
It was reported that during soft ureteroscopy lithotripsy, the fiber broke inside the patient.Device was removed from the patient's body and procedure was completed with another of the same device.There were no patient complications.

• Brand Name: SLIMLINE 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: 15995873
• Report Number: 2124215-2022-53055
• Device Sequence Number: 14942754
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/28/2023

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: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0086220222
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 09/21/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/16/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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