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

Model Number 0644-020-01

Device Problem Break (1069)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that during a photo selective vaporization of the prostate procedure for kidney stones, while using a storz mip-m nephoscope and slimline fiber with settings were 1.5j 15hz, 22.5 watts, the fiber snapped when it entered in the nephoscope and it burnt the surgeon on his left hand, breached the glove and caused a second-degree burn injury at 2 points, later vaseline was applied to the burn.The procedure was completed with another device without patient complications.

Manufacturer Narrative

Based on the information available, the cause that contributed to the reported fiber break cannot be established as the product is not available for analysis.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.However, it could be possible that the procedural handling and conditions could contributed to the fiber break.This kind of anomaly could be due to that during use and when it was inserted into the scope and fired, it could lead 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 use 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 photo selective vaporization of the prostate procedure for kidney stones, while using a storz mip-m nephoscope and slimline fiber with settings were 1.5j 15hz, 22.5 watts, the fiber snapped when it entered in the nephoscope and it burnt the surgeon on his left hand, breached the glove and caused a second-degree burn injury at 2 points, later vaseline was applied to the burn.The procedure was completed with another device without patient complications.

• 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: 18721571
• MDR Text Key: 336635429
• Report Number: 2124215-2024-08791
• 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: 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: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0013980323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• 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
• Patient Outcome(s): Required Intervention