MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CENTRA BIOPSY FORCEPS SERRATED NEEDLE

Model Number	711250
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, five opened devices were returned for investigation to steris endoscopy for review.Upon review, it was found that the jaws of all five devices were able to be opened and closed without issue.Two of the devices had bends and curves in the spring sheath which could indicate over articulation of the device during use.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.
Event or Problem Description
The user facility reported that their centra biopsy forceps serrated needle was pulling the tissue and not cutting cleanly, which led to extra bleeding.The user had to release the tissue multiple times; however, the procedure was completed.

• Brand Name: CENTRA BIOPSY FORCEPS SERRATED NEEDLE
• Common Device Name: CENTRA BIOPSY FORCEPS
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19042450
• Report Number: 1528319-2024-00026
• Device Sequence Number: 15594756
• Product Code: FCL
• UDI-Device Identifier: 00724995180645
• UDI-Public: 00724995180645
• 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
• Report Date (Section B): 04/04/2024

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: 711250
• Device Catalogue Number: 711250
• Device Lot Number: 070916, 066759
• 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: 03/05/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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