MAUDE Adverse Event Report: US ENDOSCOPY BIOSHIELD; BIOSHIELD BIOPSY VALVE

Model Number	00711126
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, fluid from the bioshield biopsy valve was leaking onto the floor.No report of injury.

• Brand Name: BIOSHIELD
• Common Device Name: BIOSHIELD BIOPSY VALVE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25576603
• Report Number: 1528319-2026-00072
• Device Sequence Number: 5154471
• Product Code: ODC
• UDI-Device Identifier: 00724995183509
• UDI-Public: (01)00724995183509(11)251028(17)281028(10)12929290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232951
• 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): 06/22/2026

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: 00711126
• Device Catalogue Number: 00711126
• Device Lot Number: (10)12929290
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 10/28/2025
• 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