MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK

Model Number	SBT-546-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a blox bite block was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021 according to the complainant, during the procedure, it was noted that the bite blox was broken into pieces.No debris were found inside the patient's mouth and the broken pieces was retrieved by hand.The procedure was completed with the another bite blox.There were no patient complications reported as a result of this event.

• Brand Name: BLOX
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11734154
• Report Number: 3005099803-2021-01948
• Device Sequence Number: 3192872
• Product Code: MNK
• UDI-Device Identifier: 00840253104809
• UDI-Public: 00840253104809
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: SBT-546-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1