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

Model Number	00711250
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned for evaluation.Investigation in progress.A follow-up mdr will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their centra biopsy forceps had a "broken handle" and were "stiff." these issues resulted in reported "instances of the forceps tearing the mucosa.".
Additional Manufacturer Narrative
The procedure was completed successfully utilizng another set of centra biopsy forceps without report of procedure delay.Four devices were returned to the supplier for further evaluation.The supplier reported that all the forceps worked as expected.The reported issue could not be duplicated.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." a steris clinical specialist conducted in-service training on the proper use of the centra biopsy forceps serrated needle.No additional issues have been reported.

• Brand Name: CENTRA
• Common Device Name: CENTRA BIOPSY FORCEPS
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20316281
• Report Number: 1528319-2024-00079
• Device Sequence Number: 7669245
• Product Code: FCL
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645(11)231223(17)261223(10)076220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Device Lot Number: (10)076220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2023
• 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