MAUDE Adverse Event Report: OVESCO ENDOSCOPY USA INC. BOUGIECAP; DILATOR, ESOPHAGEAL

Model Number	17/18
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The bougie cap was placed on the scope and following the ifu [instructions for use] placing the provided adhesive tape.This tape is clear and completely colorless, poses difficulty seeing post procedure for removal.Tape is single use and meant for removal after patient use.Not intended for reprocessing.

• Brand Name: BOUGIECAP
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): OVESCO ENDOSCOPY USA INC.; 15300 weston parkway; suite 101; cary NC 27513
• MDR Report Key: 24150107
• Report Number: 24150107
• Device Sequence Number: 9369137
• Product Code: KNQ
• UDI-Device Identifier: 04260206311485
• UDI-Public: (01)04260206311485(17)280331(10)861065
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026
• Report Date (Section F): 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: Other
• Device Model Number: 17/18
• Device Catalogue Number: 400.32.04
• Device Lot Number: 861065
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2026
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/06/2026