MAUDE Adverse Event Report: US ENDOSCOPY CENTRA; CENTRA BIOPSY FORCEPS

Model Number	00711250
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The centra 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.The lot number for the centra biopsy forceps was not provided by user facility personnel.Without the lot number, a review of the device history record could not be performed.Steris made multiple attempts to contact the user facility to obtain additional information regarding the reported event and to have the centra biopsy forceps subject of the reported event returned for evaluation however, the user facility has not responded.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that during a patient procedure, the centra biopsy forceps were "pulling the tissue" resulting in bleeding.No report of procedure delay.

• Brand Name: CENTRA
• Common Device Name: CENTRA 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: 25695613
• Report Number: 1528319-2026-00077
• Device Sequence Number: 9747453
• Product Code: PTS
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/02/2026

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
• 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: 06/05/2026
• Initial Report FDA Received Date: 07/02/2026
• 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