MAUDE Adverse Event Report: LUMENIS LTD LUMENIS XPEEDA DSL FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	1912-11
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber deteriorated during the procedure and at the end of the procedure, the tip detached.The procedure was completed without any patient complications.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Neither the console nor components were returned, but the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was found that the reported error 157 displayed by the console was caused by damage to the solenoid single method.Following replacement of this component and device recalibration the device passed full functional testing.No further issues were identified during service the clinical observation was confirmed by analysis; the damaged solenoid could have affected the console performance and its integrity, leading to the reported event and error issued; based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.D3/g1 additional email: (b)(4).
Event or Problem Description
It was reported that the fiber deteriorated during the procedure and at the end of the procedure, the tip detached.The procedure was completed without any patient complications.

• Brand Name: LUMENIS XPEEDA DSL FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; hakidman st. 6; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17221913
• Report Number: 2124215-2023-33450
• Device Sequence Number: 6969577
• Product Code: GEX
• UDI-Device Identifier: 07290109140278
• UDI-Public: 07290109140278
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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 Model Number: 1912-11
• Device Catalogue Number: 1912-11
• Device Lot Number: 0012340223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Patient Sex: Unknown