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

Model Number 840-925

Device Problem Break (1069)

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

Event Date 04/09/2024

Event Type  malfunction  

Event Description

It was reported that during a percutaneous nephrolithotomy procedure for kidney stones, the fiber snapped in half inside the patient.Due to this, the procedure was completed using an alternate fiber.There were no patient complications.

• Brand Name: LUMENIS SLIMLINE SIS REUSABLE LASER FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; 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: 19197444
• MDR Text Key: 341424183
• Report Number: 2124215-2024-25226
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140247
• UDI-Public: 07290109140247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 840-925
• Device Catalogue Number: 840-925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1