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

Model Number	GA-0006000
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3.Manufacturer email: (b)(4).
Event or Problem Description
It was reported that error 67 occurred prior to the ureteroscopic lithotripsy (ursl) stone removal procedure starting.Two different fibers were attempted to be used with the console.However, the procedure was then cancelled due to the error received stating the fiber expired.The customer would not provide information regarding whether there were any patient complications or whether the patient was sedated.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Event or Problem Description
It was reported that error 67 occurred prior to the ureteroscopic lithotripsy (ursl) stone removal procedure starting.Two different fibers were attempted to be used with the console.However, the procedure was then cancelled due to the error received stating the fiber expired.The customer would not provide information regarding whether there were any patient complications or whether the patient was sedated.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, this console was serviced at the customer's facility by a field service engineer (fse).The fse checked the console and verified the laser, debris shield and fibers.The fse found that the fiber had exceeded the available number of usages.The console was in working condition.It is probable that the reported event was caused by the fibers being expired.Based on the information available, the complaint is assigned the conclusion code of no problem detected because there was no damage or malfunction identified.

• Brand Name: PULSE
• 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: 17746422
• Report Number: 2124215-2023-49947
• Device Sequence Number: 12175859
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: GA-0006000
• Device Catalogue Number: GA-0006000
• Device Lot Number: 0000000544
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown