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

Model Number	M00420020220
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6).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 device was unable to start and instead booted into a blue bios screen, consequently, the procedure was cancelled.The status of the patient's sedation when the cancellation occurred is unknown.A labsystem pro clearsign ii amplifier was selected for use.During preparation, the device was unable to start and instead booted into a blue bios screen, consequently, the procedure was cancelled.There were no patient complications.It is not known whether the device will be returned for analysis.This is being reported for cancellation of the procedure with sedation status unknown.
Additional Manufacturer Narrative
Block e1: (b)(6).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 device was unable to start and instead booted into a blue bios screen, consequently, the procedure was cancelled.The status of the patient's sedation when the cancellation occurred is unknown.A labsystem pro clearsign ii amplifier was selected for use.During preparation, the device was unable to start and instead booted into a blue bios screen, consequently, the procedure was cancelled.There were no patient complications.It is not known whether the device will be returned for analysis.This is being reported for cancellation of the procedure with sedation status unknown.As per additional information received on february 9, 2026, the reported issue was confirmed, and no additional issues were identified.The workstation could no longer be started, displaying the blue bios entry prompt.The cmos battery was measured at 2.8 v and replaced, after which the bios settings were reconfigured.A functional test was then performed.The system is fully functional and ready for use, and confirmed to be fully operational.The repair of the lspro was carried out according to the tausch workstation safety checklist.A safety inspection was also performed, and an stk with functional and electrical safety testing was completed.

• 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: 24209751
• Report Number: 2124215-2026-05226
• Device Sequence Number: 13168013
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: (01)08714729884897(11)230105(10)1E870199
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 1E870199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 05/01/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/11/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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