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

Model Number SBT-114-100

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 199511350
• Report Number: 3005099803-2020-02722
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SBT-114-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1