MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS; POWERED LASER SURGICAL INSTRUMENT

Model Number	0644-010-01
Medical Device Problem Codes	Break (1069); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, it was found that both the fiber and debris shield were broken.The fiber was broken at the fiber tip, and then the fiber stopped working.It was noted there were no device issue with connecting the fiber to the console and the fiber was recognized by the console when it was connected.This report is for the fiber break.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during the lithotripsy procedure, it was found that both the fiber and debris shield were broken.The fiber was broken at the fiber tip, and then the fiber stopped working.It was noted there were no device issue with connecting the fiber to the console and the fiber was recognized by the console when it was connected.The fiber was replaced, and the procedure was completed using the second fiber.There were no patient complications.This report is for the fiber break.

• Brand Name: SLIMLINE SIS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18039377
• Report Number: 2124215-2023-60647
• Device Sequence Number: 7531058
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: 07290109140223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 0644-010-01
• Device Catalogue Number: 0644-010-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown