MAUDE Adverse Event Report: US ENDOSCOPY; BITE BLOCK MAXI, LATEX FREE STRAP

Model Number	00712804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has contacted the user facility requesting additional information regarding the reported event.To date, we have not received additional information.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.The bite block maxi, latex free strap is provided by a third-party supplier who has been made aware of the reported issue.
Event or Problem Description
The user facility reported that during a patient procedure a piece of their bite block maxi, latex free strap detached and had to be removed from the patient using a scope.No report of injury.

• Brand Name: NA
• Common Device Name: BITE BLOCK MAXI, LATEX FREE STRAP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20476630
• Report Number: 1528319-2024-00089
• Device Sequence Number: 8267092
• Product Code: MNK
• UDI-Device Identifier: 00724995184162
• UDI-Public: (01)00724995184162(11)230426(17)260426(10)5743773
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/17/2024

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 Expiration Date: 04/26/2026
• Device Model Number: 00712804
• Device Catalogue Number: 00712804
• Device Lot Number: (10)5743773
• 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: 09/18/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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