MAUDE Adverse Event Report: LUMENIS LTD LUMENIS SLIMLINE 200 D/F/L; POWERED LASER SURGICAL INSTRUMENT

Model Number	1911-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Burn(s) (1757); Laceration(s) (1946)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during handling of this fiber laser, the fiber snapped and burned the hand of the nurse.It was said that the nurse was reported be in good condition and no further treatment was necessary.Another fiber was used to continue the case.
Additional Manufacturer Narrative
B5: describe event or problem and h6: patient codes have been updated.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 implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that during handling of this fiber laser, the fiber snapped and pierced the hand of the nurse.It was said that the nurse was reported be in good condition and no further treatment was necessary.Another fiber was used to continue the case.
Additional 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 implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Additional Manufacturer Narrative
Based on the information available, there was no device available for analysis.However, the information provided states there was an error by the nurse when handling the fiber.It is probable that the handling of the fiber by the nurse led to the fiber break and subsequent burn to the nurse's hand.The instructions for use (ifu) states: careful handling of the fiber during setup is important to prevent fiber damage.Fiber damage may impact fiber performance.Inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.A damaged fiber-optic cable may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.The reported patient symptom is a known risk associated with slimline fiber procedures and is noted as such in the instructions for use.The interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.
Event or Problem Description
It was reported that during handling of this fiber laser, the fiber snapped and burned the hand of the nurse.It was said that the nurse was reported be in good condition and no further treatment was necessary.Another fiber was used to continue the case.

• Brand Name: LUMENIS SLIMLINE 200 D/F/L
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19576373
• Report Number: 2124215-2024-37219
• Device Sequence Number: 8524933
• Product Code: GEX
• UDI-Device Identifier: 07290109140261
• UDI-Public: 07290109140261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2025
• Device Model Number: 1911-07
• Device Catalogue Number: 1911-07
• Device Lot Number: 0000902303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 08/07/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/05/2024; 08/28/2024
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown