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

Model Number	0644-018-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to treat ureter and bladder stones, the fiber physically broke.It was noted that no significant bend deflection was required to reach the treatment site.A second fiber was used; however, this fiber tip overheated and burnt and needed to be replaced by a third fiber to complete the procedure.There were no operator or patient complications.
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 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, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure to treat ureter and bladder stones, the fiber physically broke.It was noted that no significant bend deflection was required to reach the treatment site.A second fiber was used; however, this fiber tip overheated and burnt and needed to be replaced by a third fiber to complete the procedure.There were no operator or patient complications.

• Brand Name: SLIMLINE SIS EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16756685
• Report Number: 2124215-2023-17600
• Device Sequence Number: 20964418
• Product Code: GEX
• UDI-Device Identifier: 17290109140206
• UDI-Public: 17290109140206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: 0644-018-01
• Device Catalogue Number: 0644-018-01
• Device Lot Number: 0004771022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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