MAUDE Adverse Event Report: US Endoscopy Centra; Biopsy Forceps

Model Number	00711247
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure user facility personnel were having trouble grabbing the tissue with their centra biopsy forceps subsequently causing the patient to obtain a hematoma.The procedure was completed successfully utilizing the same device.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, a cause of the reported event could not be determined.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.User facility personnel received in-service training on the proper use and operation of the centra biopsy forceps.No additional issues have been reported.

• 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 ; +1(440)259-7401
• MDR Report Key: 50005850
• Report Number: 1528319-2026-00089
• Device Sequence Number: 10383118
• Product Code: PTS
• UDI-Device Identifier: 00724995180621
• UDI-Public: (01)00724995180621(11)260424(17)290423(10)113974
• 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): 07/23/2026

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: 00711247
• Device Catalogue Number: 00711247
• Device Lot Number: (10)113974
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2026
• 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