MAUDE Adverse Event Report: US ENDOSCOPY CENTRA; BIOPSY FORCEPS

Model Number	00711250
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The centra disposable biopsy forceps subject of the reported event were discarded and not available for return or evaluation.Without the return and evaluation of the centra disposable biopsy forceps the cause of the reported event could not be determined.The lot number for the centra disposable 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 offered in-service training on the proper use and operation of the centra disposable biopsy forceps however, the user facility declined.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 disposable biopsy forceps were not able to "bite" the tissue subsequently causing a perforation.The perforation was closed with clips and user facility personnel elected to continue the procedure with the device, and the procedure was completed successfully.No report of injury.

• 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: 25243228
• Report Number: 1528319-2026-00055
• Device Sequence Number: 10500858
• Product Code: PTS
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645
• Combination Product (Y/N): N
• Initial Reporter State: FM
• 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): 05/21/2026

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: 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: 04/21/2026
• Initial Report FDA Received Date: 05/21/2026
• 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