MAUDE Adverse Event Report: US ENDOSCOPY BIOVAC; SUCTION DEVICE

Model Number	00711513
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report (b)(4), that during a patient procedure the tubing clamp that connects the suction barb was missing from their biovac direct suction device.No report of injury or procedure delay.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without return of the device, a root cause cannot be determined.Multiple attempts were made to obtain additional information from the user facility; however, the user facility did not respond.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A 3-year complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: BIOVAC
• Common Device Name: SUCTION DEVICE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 21283346
• Report Number: 1528319-2025-00006
• Device Sequence Number: 9355215
• Product Code: KQT
• UDI-Device Identifier: 00724995183806
• UDI-Public: (01)00724995183806(11)220324(17)250323(10)2203344
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/31/2025

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: 03/23/2025
• Device Model Number: 00711513
• Device Catalogue Number: 00711513
• Device Lot Number: (10)2203344
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2022
• 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