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

Model Number	00711249
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for investigation.Without the return of the complaint device, the complaint cannot be confirmed, and the exact cause of the reported issue cannot be determined.The instructions for use provides the following information to the user: "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.The customer accepted and will provide in-service training on june 25th, 2024.
Event or Problem Description
The user facility reported two instances of post biopsy bleeding following use of the centra biopsy forceps.The first patient was treated with hemoclips during the procedure, causing a procedure delay.The second patient was treated days later with no additional endoscopy.The user facility also reported difficulty passing the centra biopsy forceps through the endoscope channel.

• Brand Name: CENTRA BIOPSY FORCEPS
• Common Device Name: 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: 19553612
• Report Number: 1528319-2024-00049
• Device Sequence Number: 15155008
• Product Code: FCL
• UDI-Device Identifier: 00724995180638
• UDI-Public: 00724995180638
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/17/2024

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: 00711249
• Device Catalogue Number: 00711249
• 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: 05/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/30/2024
• 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