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

Model Number	1911-07
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber was broken.
Event or Problem Description
It was reported that during the stone procedure the fiber was broken when it was removed from the packaging.A second fiber was used to complete the procedure without any clinical consequences to the patient.
Event or Problem Description
It was reported that during the stone procedure the fiber was broken when it was removed from the packaging.A second fiber was used to complete the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, 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, h6 evaluation conclusion code.

• 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 9468 ; GM 9468
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15214461
• Report Number: 2124215-2022-30232
• Device Sequence Number: 20234825
• Product Code: GEX
• UDI-Device Identifier: 07290109140261
• UDI-Public: 07290109140261
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 09/21/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/06/2022; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2022
• 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