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

Model Number	00711250
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, their biopsy forceps were not cutting properly resulting in tearing of the tissue.The user facility did not disclose if medical treatment was sought or administered.No report of procedure delay.
Additional Manufacturer Narrative
Without the return or inspection of the subject device, a root cause cannot be determined.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 follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: 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: 19731422
• Report Number: 1528319-2024-00058
• Device Sequence Number: 8328072
• Product Code: FCL
• UDI-Device Identifier: 00724995180645
• UDI-Public: 00724995180645
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/12/2024

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
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/12/2024
• 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