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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to 07/01/2025 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during a procedure on unknown date.It was reported that the bite blox was found to be broken upon removal from its individual packaging.A new device from the same lot was opened and used to successfully complete the procedure.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during a procedure on unknown date.It was reported that the bite blox was found to be broken upon removal from its individual packaging.A new device from the same lot was opened and used to successfully complete the procedure.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to 07/01/2025 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Block h11: the returned bite blox was analyzed.A break was identified in one of the side handles.No signs of usage were observed.No other damages or defects were observed.Product analysis confirmed the reported event: the bite blox was broken.However, due to the absence of bite marks on the device, it is unlikely that it was used.A review of the device history record (dhr) from two probable lots confirmed that the device met all material, assembly, and performance specifications at the time of release for distribution.Therefore, the damage is unlikely to be related to manufacturing.Based on a comprehensive review and analysis of all available information, the most probable cause is cause traced to component failure, indicating that the noted damage resulted from an expected or random component failure without any design or manufacturing defect.

• 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
• Manufacturer (Section G): JIANGSU JIANYU HEALTH MEDICAL CO LT; no 88 of longxi avenue; zhulin town; changzhou city 21324 1; CH 213241
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22586335
• Report Number: 3005099803-2025-03577
• Device Sequence Number: 9393073
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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
• Device Catalogue Number: SBT-114-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown