MAUDE Adverse Event Report: US ENDOSCOPY; BITE BLOCK

Model Number	00712804
Medical Device Problem Codes	Material Discolored (1170); Insufficient Device Problem Information (3190)
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 (b)(4) that there were brown dots observed on the plastic package of their bite block.The bite block was not utilized in a patient procedure.No report of injury.
Additional Manufacturer Narrative
Steris requested the bite block subject of the reported event be returned for evaluation.The bite block instructions for use states, "inspect bite block and should there be evidence of any defects or damage do not use this product and contact your local product specialist." the device history record was reviewed for the subject lot and no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting an mdr solely due to the receipt of the user facility medwatch report which is in accordance with our policies and procedures.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The bite block subject of the reported event was returned for evaluation.During evaluation, brown spots were confirmed to be on the plastic package and the device.The spots could not be wiped off or removed.The source of the spots could not be determined.The bite block was not utilized in a patient procedure.This is an isolated event.Steris will continue to monitor post-market data to ensure the device continues to perform as intended.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: BITE BLOCK
• 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: 21767011
• Report Number: 1528319-2025-00026
• Device Sequence Number: 18288269
• Product Code: MNK
• UDI-Device Identifier: 00724995184162
• UDI-Public: (01)00724995184162(11)241011(17)271011(10)11155940
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/03/2025

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 Model Number: 00712804
• Device Catalogue Number: 00712804
• Device Lot Number: (10)11155940
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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