MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOSHIELD BIOSPY VALVE; BIOPSY VALVE

Model Number	00711125
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined in-service training.The director of regional sales-healthcare and the territory manager reviewed the proper way of seating the valve and how to pass the device through the endoscope.The device was not retained by the user facility for evaluation.The customer reviewed with the staff the importance of not discarding the device if the there are any issues in the future.The instructions for use tells the user the following information: "a variety of (8) different bioshield biopsy valves are available.Bioshield biopsy valve (part #00711125, #00711124, #00711126, #00711129, #00711133, #00711135) is used to cover the opening to the biopsy/suction channel of olympus (excluding olympus linear eus endoscopes) and g5 series and newer fujifilm gastrointestinal endoscopes only.Exposure to bodily fluids may occur during connection or disconnection of these devices; adherence to body substance isolation protocols is the responsibility of the user.Do not use a sharp or pointed object to prime the valve prior to use.Do not leave a device hanging from the valve.Doing so can cause the creation of a larger valve slit/hole that may cause leakage.If the lid of the valve is opened while attached to the endoscope during a procedure, scope suction will be compromised, and leakage may occur.If leakage occurs, a sterile gauze should be used to cover the valve." the device history record (dhr) was reviewed, and no abnormities were noted for this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, spray from the bioshield biopsy valve made contact with the physician.No harm to patient or users was reported.

• Brand Name: BIOSHIELD BIOSPY VALVE
• Common Device Name: BIOPSY VALVE
• 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: 19033338
• Report Number: 1528319-2024-00024
• Device Sequence Number: 8035892
• Product Code: OCX
• UDI-Device Identifier: 10724995183490
• UDI-Public: 10724995183490
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/03/2024

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: 00711125
• Device Catalogue Number: 00711125
• Device Lot Number: 7109883
• 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: 03/04/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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