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

Model Number	SBT-114-100
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an oral endoscopy performed on (b)(6) 2023.During the procedure, the mouthpiece got bitten strongly by the patient and cracked including the rim part.The endoscope also got bitten and damaged.It was not reported how was the procedure completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Block h11: block b5 has been corrected.Block h6 device code has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during an oral endoscopy performed on (b)(6) 2023.During the procedure, the mouthpiece got bitten strongly by the patient and cracked including the rim part.There is a crack in the main body.The endoscope also got bitten and damaged.It was not reported how was the procedure completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0413 captures the reportable event of bite blox material separation.Investigation results: the returned bite blox was analyzed.The visual evaluation found that the bite blox housing was damaged; a large crack was seen and the presence of bite marks.No other problems were noted.The reported event was confirmed.Product analysis identified that the bite blox housing was damaged, a large crack was seen and the presence of bite marks were noted.It is likely that compressive bite force caused the bite blox housing to be damaged as evidenced by the presence of bite marks.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during an oral endoscopy performed on (b)(6) 2023.During the procedure, the mouthpiece got bitten strongly by the patient and cracked including the rim part.There is a crack in the main body.The endoscope also got bitten and damaged.It was not reported how was the procedure completed.There were no patient complications reported 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16824734
• Report Number: 3005099803-2023-02201
• Device Sequence Number: 6987609
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2023

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: 0000220818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 06/13/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/18/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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