MAUDE Adverse Event Report: OVESCO ENDOSCOPY USA OTSC SYSTEM SET

Catalog Number	100.31
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Esophagus (2399); Upper Respiratory Tract Injury (4599)
Type of Reportable Event	Death
Event or Problem Description
An intubated patient underwent endoscopic treatment of upper digestive bleeding in the stomach.The treatment was done by means of an otsc clip and was successful in terms of closure of the ulcerative bleeding site.After the procedure, a tracheal perforation and an esophageal lesion were found and the patient was admitted to the icu.The clinical course was complicated, and the patient eventually passed away.
Additional Manufacturer Narrative
An intubated patient underwent endoscopic treatment of upper digestive bleeding in the stomach.The treatment was done by means of an otsc clip and was successful in terms of closure of the ulcerative bleeding site.After the procedure, a tracheal perforation and an esophageal lesion were found and the patient was admitted to the icu.The clinical course was complicated, and the patient eventually passed away.We were notified that the gastroenterologist deemed the otsc system not likely to be the reason for the complication.After multiple enquiries at the hospital no further information was available and the injury mechanism in the intubated patient remained unclear.

• Brand Name: OTSC SYSTEM SET
• Common Device Name: OTSC SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY USA; 15300 weston parkway; suite 101; cary NC 27513
• Manufacturer (Section G): OVESCO ENDOSCOPY USA; 15300 weston parkway; suite 101; cary NC 27513
• Manufacturer Contact: gregory stohl ; 15300 weston parkway; suite 101; cary, NC 27513 ; 9196519449
• MDR Report Key: 25116916
• Report Number: 3008720584-2026-00001
• Device Sequence Number: 10232142
• Product Code: PKL
• UDI-Device Identifier: 04260206311690
• UDI-Public: 04260206311690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101428
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100.31
• Device Lot Number: 25J017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Unknown