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

Model Number 0644-020-01

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that during a procedure, a fiber burnt the finger of the surgeon.The surgeon reported the burn was painful and a little deep, but it healed, and he did not have to visit the emergency department.The burn site is still sensitive, especially when he has to hold on tight to a fairly hard surface.The procedure was completed using another fiber without patient complications.

Event Description

It was reported that during a procedure, a fiber broke at the point of entry into the scope, which burnt the finger of the surgeon.The surgeon reported the burn was painful and a little deep.He did not have to visit the emergency department.He treated the burnt area with cold water and an absorbent dressing for three weeks.The finger is now healed but the burn site is still sensitive, and painful under pressure.The procedure was completed using another fiber without patient complications.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms 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 procedure, a fiber broke at the point of entry into the scope, which burnt the finger of the surgeon.The surgeon reported the burn was painful and a little deep.He did not have to visit the emergency department.He treated the burnt area with cold water and an absorbent dressing for three weeks.The finger is now healed but the burn site is still sensitive, and painful under pressure.The procedure was completed using another fiber without patient complications.

• Brand Name: SLIMLINE SIS EZ
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 18756779
• MDR Text Key: 335940997
• Report Number: 2124215-2024-10451
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0092710522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/18/2024
• Supplement Dates FDA Received: 03/12/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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): Other