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

Model Number	GA-2006098
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during endoscopic retrograde cholangiopancreatography (ercp) procedure, the fiber was or recognized by the system, "fiber cannot be connected" message was prompted by the system.The procedure could not be completed, the physician placed a balloon device to place a stent instead.There were no patient complications.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
B5 has been updated with the additional information.
Event or Problem Description
It was reported that during endoscopic retrograde cholangiopancreatography (ercp) procedure, the fiber was or recognized by the system, "fiber cannot be connected" message was prompted by the system, this event delayed the procedure 20 minutes.The procedure could not be completed, the physician placed a balloon device to place a stent instead.There were no patient complications.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 device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The field service was performed, routine check after fiber issues with laser, the costumer was able to get laser working on their own, but wanted it checked out before using again.The system passes the test as was deemed ready to use.Since the investigation was unable to identify any damage or malfunction related to the reported allegation, the investigation conclusion code selected for the complaint was no problem detected.Incident description (b5) has been updated with additional information.
Event or Problem Description
It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the fiber was not recognized by the system and the message "fiber cannot be connected" was prompted.This event delayed the procedure 20 minutes.The procedure could not be completed, and the physician used a balloon device to place the stent instead.There were no patient complications reported.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia or whose sedation status was unknown.

• 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; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20976722
• Report Number: 2124215-2024-77070
• Device Sequence Number: 15573625
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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-2006098
• Device Catalogue Number: GA-2006098
• Device Lot Number: 0000000521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 01/17/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/10/2025; 01/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female