MAUDE Adverse Event Report: NEPTUNE MEDICAL, INC. PATHFINDER ENDOSCOPE OVERTUBE

Model Number	GI 110160-2
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to neptune medical for investigation.The trimming of the tip was confirmed by the employee that performed the action.Unknown lot number; based on shipments to site, date of manufacture may be in may 2024 or oct 2024.
Event or Problem Description
A patient was admitted for colonoscopy to remove a foreign body that had migrated to the distal colon.The md determined that the device would be a useful tool to help with the removal of the foreign body, and requested the overtube for the procedure.Upon examination of the device by the physician performing the procedure, the physician asked that the distal tip (tapered portion) of the device be trimmed to create a larger working channel.At the request of the md, a company employee trimmed the distal tip using scissors.The device was inserted into the patient and the procedure was completed without incident.The device is a hollow tube for use over a flexible gastrointestinal endoscope.The endoscope is inserted through the proximal end of the device and comes out the distal end.The distal tip is a tapered, atraumatic silicone tip that is attached to the distal end of pathfinder.Per internal documentation, the potential harm in the event the atraumatic tip is lost and the device is inserted into the patient is gi tract damage up to and including perforation of patient anatomy requiring surgical intervention.There was no reported adverse event or harm occurring in this case.

• Brand Name: PATHFINDER ENDOSCOPE OVERTUBE
• Common Device Name: PATHFINDER ENDOSCOPE OVERTUBE
• Manufacturer (Section D): NEPTUNE MEDICAL, INC.; 1828 el camino real; ste 508; burlingame CA 94010
• Manufacturer (Section G): NEPTUNE MEDICAL, INC.; 1828 el camino real; ste 508; burlingame CA 94010
• Manufacturer Contact: cheuk tang ; 1828 el camino real; ste 508; burlingame, CA 94010
• MDR Report Key: 21036387
• Report Number: 3015451828-2024-00009
• Device Sequence Number: 12910099
• Product Code: FED
• UDI-Device Identifier: 00850006222087
• UDI-Public: (01)00850006222087
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2024

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: GI 110160-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown