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

Model Number SBT-114-100

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12091541
• MDR Text Key: 259145703
• Report Number: 3005099803-2021-02990
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1