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

Model Number	0642-393-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the patient's right ureteral soft lens laser lithotripsy, the fiber was fractured at the entrance of the soft lens working channel.The fiber was immediately replaced with a new fiber to continue the procedure.There were no patient complications.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, the reported allegation could not be confirmed.However, the procedural handling and procedural conditions of the device during set-up and use contributed to the fiber body break.A partial body break or kink could have occurred during use, when it was inserted into the scope.A device history record review was not performed because there is information provided from the complaint that the device was in use during the procedure, and not issues were observed prior to use, therefore rules out possible deviations within manufacturing/service processes that could have contributed to the complaint.The labeling review and risk review were not performed.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that during the patient's right ureteral soft lens laser lithotripsy, the fiber was fractured at the entrance of the soft lens working channel.The laser fiber was immediately replaced with a new fiber to continue the procedure.There were no patient complications.

• Brand Name: SLIMLINE EZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19274340
• Report Number: 2124215-2024-28262
• Device Sequence Number: 7430153
• Product Code: GEX
• UDI-Device Identifier: 17290109140169
• UDI-Public: 17290109140169
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 06/09/2025
• Device Model Number: 0642-393-01
• Device Catalogue Number: 0642-393-01
• Device Lot Number: 0061540720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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