MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BITE BLOCK

Model Number 00712804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Type  malfunction  

Manufacturer Narrative

Upon discussion with the user facility, us endoscopy learned that facility personnel attributed the reported event to an overly tight strap.The device subject of the event was not retained by the user facility for evaluation and examination.Returned product from the same lot was examined and it was found that all straps were within specification.The bite block strap is flexible and adjustable to ensure proper fit to the patient's head.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Additionally, the incoming inspection report for the strap component was reviewed and confirmed that the component lot was found to be within specifications.Statements from the device instructions for use include: "assess the patient's oral capacity to ensure it is compatible with the size requirements of the bite block.Assess patient for appropriate or intact dentition as well as oral and maxillofacial trauma prior to using and after removal of the bite block." a us endoscopy representative counseled user facility personnel on techniques for optimizing the strap fit.No further issues have been reported.

Event Description

The user facility reported an abrasion to the patient's lip during an upper endoscopic procedure which included use of a bite block.No treatment was sought or administered.

• Brand Name: BITE BLOCK
• Type of Device: BITE BLOCK
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 9289791
• MDR Text Key: 207750337
• Report Number: 1528319-2019-00040
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 00816765010693
• UDI-Public: (01)00816765010693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 00712804
• Device Catalogue Number: 00712804
• Device Lot Number: 1911727
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1