MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number	M00420020230
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the amplifier broke down mid-case.During a procedure, a labsystem pro clearsign ii amplifier was selected for use.Upon system startup, the error message "before continuing you must reset the amplifier" was displayed.Troubleshooting was performed, including two hard resets and powering on the system using three to four different startup sequences; however, the issue could not be resolved.After the fuse box was removed, the labsystem pro was successfully restarted.Despite the successful restart, the procedure was subsequently cancelled while the patient remained under general anesthesia.No patient complications were reported.

• Brand Name: LABSYSTEM PRO
• Common Device Name: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 25781212
• Report Number: 2124215-2026-37065
• Device Sequence Number: 10655921
• Product Code: DRQ
• UDI-Device Identifier: 08714729884941
• UDI-Public: (01)08714729884941(11)250107(10)1F113660
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152693
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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: M00420020230
• Device Catalogue Number: M00420020230
• Device Lot Number: 1F113660
• 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: 06/16/2026
• Initial Report FDA Received Date: 07/10/2026
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown