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

Model Number 0642-395-01

Device Problem Break (1069)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that the patient underwent a right side percutaneous nephrolithotripsis (pcnl) procedure, where it was noted that the stone to treat was much larger than expected.Therefore, it was used pneumatic ballistic lithotripsy and holmium laser to reduce the size of the stones into fragments.At the moment the nurse installed the fiber it was found to be fractured.Due to this, the fiber was not used and only lithotripsy was used in the procedure.There were no patient complications reported.

• Brand Name: SLIMLINE EZ
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidm st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18779003
• MDR Text Key: 336318359
• Report Number: 2124215-2024-11233
• Device Sequence Number: 1
• Product Code: GEX
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2024

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: 0642-395-01
• Device Catalogue Number: 0642-395-01
• Device Lot Number: 0055830420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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
• Patient Age: 63 YR
• Patient Sex: Female