MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM? PRO; amplifier and signal conditioner, transducer signal

Model Number	M00420020220
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the equipment powered on; however, the amplifier could not be connected.This is being reported for cancellation of the procedure post sedation.It was reported that prior to the procedure, the equipment powered on; however, the amplifier could not be connected.During remote support, the equipment was confirmed to be properly connected.A manual connection was attempted through the application, but the connection could not be established.The ethernet cable was also replaced; however, the problem was not resolved.It was further reported that the procedure was not completed, and the patient was sedated at the time the procedure was cancelled.It is unknown whether the patient was sedated with local or general anesthesia.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Blocks b5 and d4 (unique identifier) have been updated with additional information received on march 27, 2026 and april 16, 2026.
Event or Problem Description
It was reported that the equipment powered on; however, the amplifier could not be connected.This is being reported for cancellation of the procedure post sedation.It was reported that prior to the procedure, the equipment powered on; however, the amplifier could not be connected.During remote support, the equipment was confirmed to be properly connected.A manual connection was attempted through the application, but the connection could not be established.The ethernet cable was also replaced; however, the problem was not resolved.It was further reported that the procedure was not completed, and the patient was sedated at the time the procedure was cancelled.It is unknown whether the patient was sedated with local or general anesthesia.No patient complications were reported.The device is expected to be returned for analysis.Additional information received on march 27, 2026 and april 16, 2026.It was further reported that the device was replaced with an ls10k unit.However, the specific timing of this replacement was not explicitly specified.Furthermore, the replacement was implemented subsequently as part of a planned technology refresh due to the system's length of service and proactively support continued system performance, as resolution of the reported event could have required additional time.

• 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 -579
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 24800532
• Report Number: 2124215-2026-18748
• Device Sequence Number: 9548284
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: (01)08714729884897(11)231128(10)1E872670
• Combination Product (Y/N): N
• Initial Reporter State: 11
• Initial Reporter Country: CO
• PMA/510(K) Number: K152693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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: M00420020220
• Device Catalogue Number: M00420020220
• Device Lot Number: 1E872670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 07/22/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/20/2026; 08/06/2026
• Date Device Manufactured: 11/28/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown