MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CORP. SOLAR GI; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	SOLAR GI LGI H2O 115V
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report details a malfunction of the solar gi device, a malfunction that was not observed during use of the device on a patient.
Event or Problem Description
The pump failed, resulting in negative pressure readings.

• Brand Name: SOLAR GI
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CORP.; 180 international drive; NH
• Manufacturer (Section G): LABORIE MEDICAL TECHNOLOGIES CORP.; 180 international drive; NH
• Manufacturer Contact: thomas ; 180 international drive
• MDR Report Key: 23975313
• Report Number: 3017448360-2025-00001
• Device Sequence Number: 21508949
• Product Code: FFX
• UDI-Device Identifier: 08717775955047
• UDI-Public: 08717775955047
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: SOLAR GI LGI H2O 115V
• Device Catalogue Number: G3-6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown