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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD BLOX; ENDOSCOPIC BITE BLOCK
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JIANGSU JIANYU HEALTH MEDICAL CO LTD BLOX; ENDOSCOPIC BITE BLOCK Back to Search Results
Model Number SBT-114-100
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are 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 blox endoscopic bite block was used during a treatment for stomach performed on (b)(6) 2022.During the procedure, patient had his mouthpiece damaged by his tooth through a gastric camera while sedated.The broken fragments fell outside of the patient's mouth.The procedure completed using the original bite block.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a0413 captures the reportable event of bite blox material separation.Block h10: investigation results: the returned one bite block was analyzed, a visual evaluation was performed and the bite blox was returned in three pieces and the lower bite tray is broken and separated into two pieces.The height between bite trays could not be measured due to the damage.No other problems were noted.The reported event was confirmed.Product analysis identified that the device had a broken bite tray.It is likely that adverse procedural factors related to patient response may have contributed to the reported event.Based on all gathered information and analysis of the returned device, the adverse event occurred during the procedure and the device had no influence on the event; therefore, the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a blox endoscopic bite block was used during a treatment for stomach performed on (b)(6) 2022.During the procedure, patient had his mouthpiece damaged by his tooth through a gastric camera while sedated.The broken fragments fell outside of the patient's mouth.The procedure completed using the original bite block.There were no patient complications reported as a result of this event.
 
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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 MA 21325 1
CH  213251
Manufacturer (Section G)
JIANGSU JIANYU HEALTH MEDICAL CO LTD
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 Key14428235
MDR Text Key292390361
Report Number3005099803-2022-02681
Device Sequence Number1
Product Code MNK
UDI-Device Identifier00816849010168
UDI-Public00816849010168
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSBT-114-100
Device Catalogue NumberSBT-114-100
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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