MAUDE Adverse Event Report: US ENDOSCOPY BIOSHIELD; IRRIGATOR

Model Number	00711133
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that there was bile backflow while using their bioshield irrigator.No report of injury or procedure delay.
Additional Manufacturer Narrative
During follow-up with the distributor, it was reported that the device was leaking at the endoscope connection point during the procedure resulting in a small puddle on the floor.Additionally, it was reported that the user facility completed the procedure with a different device.The device subject of the event was returned to us endoscopy for evaluation and found that the one way valve was working properly.The reported backflow could not be duplicated.The reported leaking may have occurred if the lid of the bioshield was left open by user facility personnel during use.The instructions for use provides the following information: "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 was reviewed and no anomalies were noted.There have been no other complaints associated with this lot.The distributor offered in-service training to user facility personnel on the proper use and operation of the bioshield irrigator; however, the user facility declined.No additional issues have been reported.

• Brand Name: BIOSHIELD
• Common Device Name: IRRIGATOR
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19773469
• Report Number: 1528319-2024-00061
• Device Sequence Number: 8111049
• Product Code: OCX
• UDI-Device Identifier: 00724995183554
• UDI-Public: (01)00724995183554
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Expiration Date: 08/02/2026
• Device Model Number: 00711133
• Device Catalogue Number: 00711133
• Device Lot Number: (21)6165042
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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