MAUDE Adverse Event Report: US ENDOSCOPY CENTRA; BIOPSY FORCEPS

Model Number	00711250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The centra disposable biopsy forceps subject of the reported event are not available for evaluation.Without the return and evaluation of the centra disposable biopsy forceps, a cause of the reported events could not be determined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during patient procedures, the centra disposable biopsy forceps is "tearing the tissue" resulting in bleeding.The patient procedures were completed successfully.

• Brand Name: CENTRA
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24899281
• Report Number: 1528319-2026-00032
• Device Sequence Number: 18333909
• Product Code: PTS
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645(11)251104(17)281108(10)104971
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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 Model Number: 00711250
• Device Catalogue Number: 00711250
• Device Lot Number: (10)104971
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2025
• 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 Sex: Unknown