MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK

Model Number	SBT-546-100
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: BLOX
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8754931
• Report Number: 3005099803-2019-03396
• Device Sequence Number: 11179592
• Product Code: MNK
• UDI-Device Identifier: 00840253104809
• UDI-Public: 00840253104809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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-546-100
• Device Catalogue Number: 60264
• Device Lot Number: 0000180816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 06/01/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1