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

Model Number	840-922
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate (holep) for benign prostatic hyperplasia, the fiber broke at insertion point to scope.A second fiber was tried, and it broke too.Due to this, the procedure was completed using another device.There were no patient complications.This complaint is for the first broken fiber.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate (holep) for benign prostatic hyperplasia, the fiber broke at insertion point to scope.A second fiber was tried, and it broke too.Due to this, the procedure was completed using another device.There were no patient complications.This report is for the first broken fiber.

• Brand Name: LUMENIS SLIMLINE EZ SIS SINGLE USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22206610
• Report Number: 2124215-2025-38176
• Device Sequence Number: 7668013
• Product Code: GEX
• UDI-Device Identifier: 17290109140213
• UDI-Public: (01)17290109140213
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 840-922
• Device Catalogue Number: 840-922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LUMENIS P100.; LUMENIS P100.; STORZ 26F RESECTOSCOPE.; STORZ 26F RESECTOSCOPE.
• Patient Sex: Unknown