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

Model Number 0644-020-01

Device Problem Break (1069)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that, during the mini percutaneous nephrolithotomy procedure to treat kidney stones, the fiber had been working fine.Halfway through the procedure, the fiber broke in the fiber body near the entry port of the scope.The snapped part of the fiber was still inside the scope.The broken piece of the fiber was removed using graspers.Details regarding the type of scope used were not available.It was also confirmed that the fiber was not broken before use, and the fiber did not come into contact with any material upon removal from the package.The fiber was then trimmed with surgical scissors, and the same fiber was used to complete the procedure.It was noted that the console settings were set to 2j and 20hz power 40w.There were no patient complications and there were no injuries to any users.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that, during the mini percutaneous nephrolithotomy procedure to treat kidney stones, the fiber had been working fine.Halfway through the procedure, the fiber broke in the fiber body near the entry port of the scope.The snapped part of the fiber was still inside the scope.The broken piece of the fiber was removed using graspers.Details regarding the type of scope used were not available.It was also confirmed that the fiber was not broken before use, and the fiber did not come into contact with any material upon removal from the package.The fiber was then trimmed with surgical scissors, and the same fiber was used to complete the procedure.It was noted that the console settings were set to 2j and 20hz power 40w.There were no patient complications and there were no injuries to any users.

• Brand Name: SLIMLINE SIS EZ
• 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: 18896790
• MDR Text Key: 337659144
• Report Number: 2124215-2024-15272
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: 17290109145669
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 05/03/2024

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: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0011660623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• 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