MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BITE BLOCK - MAXI - LATEX-FREE STRAP; ENDOSCOPIC BITE BLOCK

Model Number	00712804
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One of the devices subject of the event is being returned for evaluation.Steris endoscopy offered in-service training on the proper use of the bite block; however, the user facility has declined.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during use of bite blocks, patients were obtaining cuts in their mouth.No medical treatment was sought or administered.
Additional Manufacturer Narrative
The device subject of the event will not be returned for evaluation.Without the returned device the root cause of the reported event cannot be determined.No additional issues have been reported.

• Brand Name: BITE BLOCK - MAXI - LATEX-FREE STRAP
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 13902571
• Report Number: 1528319-2022-00015
• Device Sequence Number: 4303815
• Product Code: MNK
• UDI-Device Identifier: 00724995184162
• UDI-Public: (01)00724995184162
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/25/2022

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: 2106977
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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