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

Model Number	M00420020210
Medical Device Problem Codes	Defective Device (2588); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during the procedure, an labsystem pro clearsign ii amplifier was selected for use.It was found that the sap of the device was flashing yellow and data could not be exported.There was no error message displayed.Equipment needs replacement.This issue led to the procedure being cancelled/rescheduled.No patient complications were reported.The device will not be returned for analysis.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during the procedure, an labsystem pro clearsign ii amplifier was selected for use.It was found that the sap of the device was flashing yellow and data could not be exported.There was no error message displayed.Equipment needs replacement.This issue led to the procedure being cancelled/rescheduled.No patient complications were reported.The device will not be returned for analysis.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23151066
• Report Number: 2124215-2025-67516
• Device Sequence Number: 10612224
• Product Code: DRQ
• UDI-Device Identifier: 08714729884842
• UDI-Public: (01)08714729884842(11)190923(10)1D755429
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/11/2025

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: M00420020210
• Device Catalogue Number: M00420020210
• Device Lot Number: 1D755429
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/11/2025
• Date Device Manufactured: 09/23/2019
• 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 Sex: Unknown