MAUDE Adverse Event Report: US ENDOSCOPY CENTRA; BIOPSY FORCEP

Model Number	00711247
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The steris territory manager stated that during follow-up with user facility personnel, the centra biopsy forceps were confirmed to be operating properly during pre-procedure checks.The instructions for use states, "the whole device should be checked whether there is any damage (i.E.Bend of connection part and inflexible opening and closing of forceps) before using this product.If the problem exists, please do not use." the centra biopsy forceps subject of the reported event were discarded and are not available for return or evaluation.Without the return and evaluation of the device the cause of the event could not be determined.Steris performed in-service training on the proper use and operation of the centra biopsy forceps.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure for quadrant sampling, their centra biopsy forcep was "stuck" in an open position.User facility personnel utilized another device, and the procedure was completed successfully.No report of injury.

• Brand Name: CENTRA
• Common Device Name: BIOPSY FORCEP
• 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: 25183302
• Report Number: 1528319-2026-00049
• Device Sequence Number: 10693019
• Product Code: PTS
• UDI-Device Identifier: 00724995180621
• UDI-Public: (01)00724995180621
• 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): 05/15/2026

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: 00711247
• Device Catalogue Number: 00711247
• Device Lot Number: (10)107640
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• 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
• Patient Sex: Unknown