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

Model Number	0624-148-36
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bladder neck obstruction procedure, the fiber broke.The procedure was completed without replacing the fiber.There were no patient complications.
Event or Problem Description
It was reported that during a bladder neck obstruction procedure, the fiber broke.The procedure was completed without replacing the 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 inspection found that the fiber body was broken into two pieces, therefore the reported event was confirmed.In addition, the fiber tip was degraded, indicative of fiber use.The fiber connector was analyzed, no defects on connector face was found.A slightly distortion of the beam was noted during the functional test.It is likely that procedural handling and procedural conditions of the device during set-up or use contributed to the fiber body break.A partial body break or kink could have occurred during the set up and use and when the fiber was fired caused the break.Based on these observations, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during a bladder neck obstruction procedure, the fiber broke.The procedure was completed without replacing the fiber.There were no patient complications.

• Brand Name: SLIMLINE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; israel 2069204; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19996769
• Report Number: 2124215-2024-47470
• Device Sequence Number: 20640603
• Product Code: GEX
• UDI-Device Identifier: 07290109140018
• UDI-Public: 07290109140018
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 0624-148-36
• Device Catalogue Number: 0624-148-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 10/01/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/12/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 74 YR
• Patient Sex: Male