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

Model Number	1912-11
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the laser tip fell off and exploded inside the patient.No patient harm was reported.
Additional Manufacturer Narrative
Information corrected: device codes (b6).
Event or Problem Description
It was reported that during a procedure the laser tip fell off and fragmented inside the patient.No patient harm was reported.

• 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; hakidma st 6; yorkneam 20692 04; IS 2069204
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15633123
• Report Number: 2124215-2022-42183
• Device Sequence Number: 15447449
• Product Code: GEX
• UDI-Device Identifier: 07290109140278
• UDI-Public: 07290109140278
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 09/04/2025
• Device Model Number: 1912-11
• Device Catalogue Number: 1912-11
• Device Lot Number: 0065391020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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