MAUDE Adverse Event Report: US ENDOSCOPY CENTRA; BIOPSY FORCEPS

Model Number	00711250
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not available for evaluation.Without the return or inspection of the device, a root cause cannot be determined.The lot number was not provided; therefore, a review of the device history record could not be completed.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 of the centra biopsy forceps on february 24, 2025.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.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 resulting in tearing of the tissue.Medical treatment was administered with clips being applied.

• Brand Name: CENTRA
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 21529658
• Report Number: 1528319-2025-00012
• Device Sequence Number: 20927318
• Product Code: FCL
• UDI-Device Identifier: 00724995180645
• UDI-Public: (01)00724995180645
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/05/2025

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: 02/04/2025
• Initial Report FDA Received Date: 03/05/2025
• 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