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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The centra biopsy forceps subject of the reported event was discarded by user facility personnel prior to being returned for evaluation.Without the return of the device, a cause cannot be determined.The instructions for use for the biopsy forceps 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.Do not force the distal end of the insertion portion against body cavity tissue.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.Do not insert the instrument into the endoscope while the cups are open.Otherwise, patient injury, such as perforation, bleeding, or mucous membrane damage could occur.It could also damage the endoscope and/or instrument.Biopsy may cause bleeding.If you take a large sample or press the instrument's distal end against tissue excessively, the risk of bleeding will increase.Perform biopsy on minimum necessary spots only.Potential complications: those associated with gastrointestinal endoscopy include, but are not limited to: mucosal tearing, swelling, bleeding, perforation and infection." steris conducted in-service training with user facility personnel on the proper use and operation to the centra biopsy forceps.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, their biopsy forceps were not cutting as desired causing tissue tearing and subsequent bleeding.Medical treatment was administered and the bleeding was controlled using a hemoclip.

• 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: 24952925
• Report Number: 1528319-2026-00034
• Device Sequence Number: 10048369
• Product Code: PTS
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645(11)260104(17)290103(10)107966
• 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): 04/22/2026

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)107966
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2026
• 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