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 02/08/2024

Event Type  malfunction  

Event Description

It was reported that, during the transurethral lithotripsy to treat kidney stones, the fiber tip had dislodged during use.This was the first time the fiber was being used.The procedure was completed using this fiber.There were no patient complications.It was noted that the fiber is still in use following the procedure.

Manufacturer Narrative

Correction provided in: g2 report source.Additional information provided in: b5 describe event or problem 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 transurethral lithotripsy to treat kidney stones, the fiber tip detached from the fiber body while stone fragmentation was being performed.It was noted that no error messages were received.This was the first time the fiber was being used.The procedure was completed using this fiber without any further issues.There were no patient complications.It was noted that the fiber is still in use following the procedure.

• 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): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18861553
• MDR Text Key: 337199432
• Report Number: 2124215-2024-12053
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: 07290109145556
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 04/04/2024
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1