MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 550 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number 1912-10

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that, during the holmium laser enucleation of the prostate procedure, the fiber was opened and found to have no device issues.Additionally, the fiber did not come into contact with any material upon removal from the packaging.There was no damage to the fiber upon removal from the packaging or during setting up the fiber for the procedure.Midway through firing laser, the fiber broke at the point where the fiber feeds into the cystoscope port.A rigid cystoscope was being used and a significant defection of the fiber was not required to reach the treatment site.When the break occurred, the fiber was being used at a setting of 2.0 joules and 40 hertz.It was noted there was no indication of any user error while handling the fiber.The fiber was replaced, and the second fiber was used to complete the procedure.There were no complications to the patient or the user.

Event Description

It was reported that, during the holmium laser enucleation of the prostate procedure, the fiber was opened and found to have no device issues.Additionally, the fiber did not come into contact with any material upon removal from the packaging.There was no damage to the fiber upon removal from the packaging or during setting up the fiber for the procedure.Midway through firing laser, the fiber broke at the point where the fiber feeds into the cystoscope port.A rigid cystoscope was being used and a significant defection of the fiber was not required to reach the treatment site.When the break occurred, the fiber was being used at a setting of 2.0 joules and 40 hertz.It was noted there was no indication of any user error while handling the fiber.The fiber was replaced, and the second fiber was used to complete the procedure.There were no complications to the patient or the user.

• Brand Name: LUMENIS MOSES 550 D\F\L
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19088061
• MDR Text Key: 340250243
• Report Number: 2124215-2024-22096
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: 07290109143453
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0003172310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1