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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK
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BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK Back to Search Results
Model Number SBT-546-100
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2019
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 bite block was used for an endoscopic procedure, on an unknown date.According to the complainant, there was a hair inside of the device package.Another bite block was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a bite block was used for an endoscopic procedure, on an unknown date.According to the complainant, there was a hair inside of the device package.Another bite block was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code 2969 captures the reportable event of hair found in package.Block h10: one bite blox was received in the original unopened package, for analysis.A visual evaluation of the returned device revealed that there was a hair sealed in the package with the device.No other issues were noted.Based on the condition of the device, the event most likely happened during manufacturing.Therefore, the most probable cause for this event is manufacturing deficiency.
 
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Brand Name
BLOX
Type of Device
ENDOSCOPIC BITE BLOCK
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8754931
MDR Text Key149844905
Report Number3005099803-2019-03396
Device Sequence Number1
Product Code MNK
UDI-Device Identifier00840253104809
UDI-Public00840253104809
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSBT-546-100
Device Catalogue Number60264
Device Lot Number0000180816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2019
Date Manufacturer Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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