Seal® SBC-365Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816849010113), received between May 17, 2019 and May 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A GASTROSCOPY PROCEDURE DURING FEBRUARY 2019. ACCORDING TO THE COMPLAINANT, WHILE TAKING A BIOPSY IN THE STOMACH, A TINY BLUE PARTICLE WAS NOTICED ON THE SET OF BIOPSY FORCEPS THAT WERE BEING USED. THE FORCEPS WERE REMOVED FROM THE PATIENT, AND THE PARTICLE WAS THEN REMOVED FROM THE FORCEPS AND SET ASIDE. DURING ANOTHER PASS, A SECOND BLUE PARTICLE WAS NOTICED IN THE PATIENT'S STOMACH. THE SECOND BLUE PARTICLE WAS RETRIEVED. IT WAS PRESUMED THAT IT CAME FROM THE BIOPSY CAP, AS IT WAS THE ONLY BLUE ARTIFICIAL ITEM IN THE PATH OF THE BIOPSY FORCEPS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON 17MAY2019. PROCEDURE HAPPENED ON (B)(6) 2019. THE PROCEDURE WAS COMPLETED WITH THE ORIGNAL DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621343 ↗