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

Model Number	00711250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the manufacture/expiration date are unknown; therefore, were not included in the mdr.".
Event or Problem Description
The user facility reported that during a patient procedure their centra biopsy forceps were "tearing tissue." no report of procedure delay.
Additional Manufacturer Narrative
Following the reported event, four devices were returned for evaluation.Upon review, it was determined that the jaws of all four devices were able to be opened and closed without issue.Steris has notified the supplier, ags medtech of the reported event.The devices subject of the reported event were returned to ags medtech for further evaluation.The supplier reported that the forceps worked as expected.The reported issue could not be duplicated.The ifu 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." a steris clinical specialist offered in-service training on the proper use of the centra biopsy forceps serrated needle; however, the user facility declined.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: 20482991
• Report Number: 1528319-2024-00088
• Device Sequence Number: 19885898
• Product Code: FCL
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645(11)231223(17)261222(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): 10/18/2024

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)076220; (10)076237
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 03/25/2025
• 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