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 09/14/2020

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that a bite blox was used during biopsy procedure performed on (b)(6) 2020.According to the complainant, after the procedure was completed, it was noted that the bite blox was broken.Debris were found inside the patient's mouth and were retrieved successfully.The procedure was completed with the original bite blox.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a bite blox was used during biopsy procedure performed on (b)(6) 2020.According to the complainant, after the procedure was completed, it was noted that the bite blox was broken.Debris were found inside the patient's mouth and were retrieved successfully.The procedure was completed with the original bite blox.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block h6: device code 1562 captures the reportable event of bite block material separation.Block h10: one bite blox device along with the broken piece was returned for analysis.A visual inspection was performed and found that the upper bite area has bleed cracked and broken off.Bite marks are evident on the bite area.No other issues noted.Based on the available information, it is likely that the device broke due to excessive force on the device during the procedure.The adverse event occurred during the procedure and the device had no influence on event; therefore, complaint investigation conclusion code selected is adverse event related to procedure.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the 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: 10651057
• MDR Text Key: 210609565
• Report Number: 3005099803-2020-04502
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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: 10/19/2020
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1