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

Model Number	SBT-114-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date this is a non-sterile device with no expiration date.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 bite blox was used during an endoscopy procedure performed on (b)(6) 2021 according to the complainant, during the procedure, the bite blox was chewed by the patient.It was noted that there was a crack in the bottom part where the front teeth hits.Reportedly, the broken pieced detached outside of the body.The procedure was completed with the another bite blox.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4: expiration date this is a non-sterile device with no expiration date.Block h6: device code a0413 captures the reportable event of bite blox material separation.Block h10: investigation results the returned one bite blox was analyzed, a visual evaluation was performed and the device was broken.The lower bite area had been cracked and broken off.The broken piece was not returned.Bite marks were evident on the bite area.Based on the available information, it is likely that the device broke due to excessive force on the device during the procedure.Therefore, based on all gathered information, the complaint investigation conclusion code selected is adverse event related to procedure indicating that the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: block g1 manufacturer address corrected.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during an endoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the bite blox was chewed by the patient.It was noted that there was a crack in the bottom part where the front teeth hits.Reportedly, the broken pieced detached outside of the body.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: 12091541
• Report Number: 3005099803-2021-02990
• Device Sequence Number: 14443046
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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-114-100
• Device Catalogue Number: SBT-114-100
• Device Lot Number: 0000201013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1