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	09/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• 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: 10651057
• Report Number: 3005099803-2020-04502
• Device Sequence Number: 19734203
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 10/19/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1