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

Model Number 0644-017-01

Device Problem Break (1069)

Patient Problem Burn(s) (1757)

Event Date 02/10/2024

Event Type  malfunction  

Event Description

It was reported that during a lithotripsy procedure to treat renal calculus, the fiber was introduced through the scope to perform the procedure, but a few minutes later it broke up in between the body and the glass tip, also the fiber injured one nurse of the nursing staff that was assisting the procedure.A prophylaxis for burns was applied as treatment.The procedure was completed with another fiber without patient complications.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The customer provided an image of a fiber, but it did not provide enough evidence to confirm the reported event.Although, it could be possible that the procedural handling and conditions could contributed to the fiber break.This kind of break could be due to that during use and when it was inserted into the scope and fired it led to the fiber break.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.Additionally, the reported patient symptoms of burns are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that during a lithotripsy procedure to treat renal calculus, the fiber was introduced through the scope to perform the procedure, but a few minutes later it broke up in between the body and the glass tip, also the fiber injured one nurse of the nursing staff that was assisting the procedure.A prophylaxis for burns was applied as treatment.The procedure was completed with another fiber without 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: 18785222
• MDR Text Key: 336433250
• Report Number: 2124215-2024-11441
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: 07290109145556
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0023086349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other