MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD BLOX; ENDOSCOPIC BITE BLOCK

Model Number	SBT-114-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.(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 bite blox was used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the patient moved and broke the mouth piece.The procedure was completed using the original bite blox.There was no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Block d4 and h4: the lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.Block h6: device code 1562 captures the reportable event of bite block material separation.Block h10: a bite blox along with the broken piece was received for analysis.A visual analysis of the returned device found that the upper bite area has beed cracked and broken off.No other issue was found.Based on the evaluation of the returned device, it likely that the device broke due to excessive force on the device during the procedure, possibly due to the patient biting down.Therefore, the most probable cause of the reported event is adverse event related to procedure, which indicates 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.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the patient moved and broke the mouth piece.The procedure was completed using the original bite blox.There was no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: BLOX
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): JIANGSU JIANYU HEALTH MEDICAL CO LTD; zhixi industry zone; jintan area; changzhou city 21325 1; CH 213251
• MDR Report Key: 10254338
• Report Number: 3005099803-2020-02722
• Device Sequence Number: 14097546
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1