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	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer returned gi pump for repair as it was reported the device was faulty.
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.On december 18, 2025, laborie had a meeting with the fda where in fda requested complaints for negative pressure be re-evaluated and submitted as an mdr.

• Brand Name: SOLAR GI
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CORP.; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): LABORIE MEDICAL TECHNOLOGIES CORP.; 180 international drive; portsmouth NH
• Manufacturer Contact: zulmar molina ; 180 international drive; portsmouth, NH 03801
• MDR Report Key: 24720437
• Report Number: 3017448360-2026-00001
• Device Sequence Number: 17669768
• Product Code: FFX
• UDI-Device Identifier: 08717775955047
• UDI-Public: 08717775955047
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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