MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	00711177
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A retained esophageal stent in the terminal ileum was attempted for retrieval using a steris raptor grasping device, the device malfunctioned and became embedded in the terminal ileum distal to the stent.Multiple endoscopic maneuvers were performed to disengage and retrieve the device; however, these were unsuccessful.The wires of the raptor grasping device were cut, the scope was readvanced into the terminal ileum where additional attempts at removing the distal end of the raptor were unsuccessful.

• Brand Name: RAPTOR
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5960 heisley road; mentor OH 44060
• MDR Report Key: 25408783
• Report Number: 25408783
• Device Sequence Number: 21410415
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: (01)00724995183653
• 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): 06/03/2026
• Report Date (Section F): 06/03/2026

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: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 10651787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Date Report Sent to FDA: 06/03/2026