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

Model Number 0644-017-01

Device Problem Break (1069)

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

Event Date 03/27/2024

Event Type  malfunction  

Event Description

It was reported that during a left ureteral calculi procedure, the fiber broke at the fiber body during its fourth usage.External force was not applied on the fiber.The fiber was exchanged and the procedure was completed with no patient complications.

• Brand Name: SLIMLINE SIS
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19131043
• MDR Text Key: 340829894
• Report Number: 2124215-2024-23354
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: 07290109145556
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

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: 0644-017-01
• Device Catalogue Number: 0644-017-01
• Device Lot Number: 0023087452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG