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	06/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Block g1: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used for the lungs during bronchoscopy procedure performed on (b)(6) 2026.During the procedure, the bite block was placed in the patients mouth and the patient bit down forcefully on the device, causing it to become damaged.The procedure was completed with a another of the same device.There were no patient complication 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
• 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 ; +1(914)571-6918
• MDR Report Key: 25725412
• Report Number: 3005099803-2026-02688
• Device Sequence Number: 20268224
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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
• Device Lot Number: 0000250823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2025
• 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