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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, when connecting the fiber to the console, the fiber broke and detached from the rubber connector that inserts into the laser console.Another fiber was used in order to complete the procedure.There were no patient complications reported.This report corresponds to the second of four fibers.
Additional Manufacturer Narrative
The product was not returned; therefore, no physical analysis of the product could be performed.Review of a photo of the device submitted showed that the fiber connector was detached from the fiber, confirming the reported clinical observations.Review of the device history record found no deviations that could have contributed to the reported event.Based on the available information, it is likely that a misaligned aiming beam caused the laser energy to heat an incorrect target ultimately leading to the detachment.Due to this, the most probable cause of cause traced to component failure has been applied to this complaint.
Event or Problem Description
It was reported that, during a procedure, when connecting the fiber to the console, the fiber broke and detached from the rubber connector that inserts into the laser console.Another fiber was used in order to complete the procedure.There were no patient complications reported.This report corresponds to the second of four fibers.
Additional Manufacturer Narrative
Correction made to d3 manufacturer email, g1 mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip, mfr site country, mfr site phone, mfr first and last name, mfr email the product was not returned; therefore, no physical analysis of the product could be performed.Review of a photo of the device submitted showed that the fiber connector was detached from the fiber, confirming the reported clinical observations.Review of the device history record found no deviations that could have contributed to the reported event.Based on the available information, it is likely that a misaligned aiming beam caused the laser energy to heat an incorrect target ultimately leading to the detachment.Due to this, the most probable cause of cause traced to component failure has been applied to this complaint.
Event or Problem Description
It was reported that, during a procedure, when connecting the fiber to the console, the fiber broke and detached from the rubber connector that inserts into the laser console.Another fiber was used in order to complete the procedure.There were no patient complications reported.This report corresponds to the second of four fibers.

• Brand Name: LUMENIS SLIMLINE 200 D/F/L
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer strasse 4; mittweida CA 9468 ; GM 9468
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15628685
• Report Number: 2124215-2022-41949
• Device Sequence Number: 2810033
• Product Code: GEX
• UDI-Device Identifier: 07290109140261
• UDI-Public: 07290109140261
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2024
• Device Model Number: 1911-07
• Device Catalogue Number: 1911-07
• Device Lot Number: 0085800222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 09/21/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/16/2022; 10/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown