MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE; LOW PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE

Model Number	GJ-1430-45-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in medsun report #: (b)(4), it was reported that the, "rn went to unclog the g-tube portion of the gj [gastro-jejunal] tube by instilling warm water into the extension, since the patient could not receive clog zapper due to there being maltodextrin in the zapper instillation (pt allergy).The warm water could not be advanced into the tube, so this rn irrigated the g-port with some sterile water and gauze to wash away some clogged residue, as it could be seen at the opening to the g-tube port.After irrigating some away, this rn reattached the g-tube extension and flushed with warm sterile water.As it was being flushed, the tube started leaking underneath the mic button, where the g-tube portion of the gj goes into the patient.It was discovered that a hole was underneath the mic-button.Pt underwent gj tube exchange over wire under sedation".
Additional Manufacturer Narrative
This report is a response to medsun report #(b)(4) which was received by amt from the fda on 01/26/2026.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once returned.Examination of the device was able to confirm the reported complaint that there was a tear.The user reports attempting to clear a clog prior to leakage.Over pressurization and/or contact with a sharp object should be avoided during device handling.Recent trending data shows no anomalies in reported failures from the field.The complaint information has been logged into our complaint database for trending purposes.Information regarding device investigation can be found under complaint # (b)(4).

• Brand Name: G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Common Device Name: LOW PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn dipaolo ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 24403232
• Report Number: 1526012-2026-00001
• Device Sequence Number: 15929133
• Product Code: KNT
• UDI-Device Identifier: 00842071134310
• UDI-Public: 00842071134310
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: GJ-1430-45-I
• Device Catalogue Number: GJ-1430-45-I
• Device Lot Number: 250327-297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 16 YR
• Patient Sex: Male