Seal® SBC-580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10840253110067), received between Sep 17, 2018 and Dec 11, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Material Fragmentation; Device-Device Incompatibility; Material Fragmentation; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED WITH A SPEEDBAND SUPERVIEW SUPER 7 DURING AN ESOPHAGEAL VARICES - LIGATION BANDING PROCEDURE IN THE ESOPHAGUS PERFORMED FOR THE TREATMENT OF ESOPHAGEAL VARICES ON (B)(6) 2024. DURING THE PROCEDURE, THE CAP OF SEAL BIOPSY VALVE WAS DETACHED WHEN THE PHYSICIAN PLACED THE SPEEDBAND LIGATION DEVICE ONTO THE BIOPSY CAP. THE BIOPSY CAP FELL INTO THE WORKING CHANNEL OF THE SCOPE AND THEN INSIDE THE PATIENT'S BODY. THE FRAGMENT WAS RETRIEVED BY THE PHYSICIAN USING FORCEPS. IT WAS REPORTED THAT THE METAL ROD OF THE SPEEDBAND CAUSED THE DETACHMENT WHEN IT WAS SEATED ONTO THE BIOPSY CAP. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL SEAL BIOPSY VALVE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907274 ↗
• MalfunctionMay 3, 2019Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BIOPSY CAP POPPED OFF FROM THE BIOPSY PORT OF THE SCOPE CAUSING FLUIDS TO SPRAY EVERYWHERE. THEY WERE ABLE TO COMPLETE THE CASE WITH THIS DEVICE. THERE WAS NO SERIOUS INJURY NOR ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577746 ↗
• MalfunctionJan 15, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY/ESOPHAGOGASTRODUODENOSCOPY(EGD) PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE BIOPSY CAP WAS LEAKING AND SPRAYING BODILY FLUID. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248943 ↗
• MalfunctionSep 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LID OF THE SEAL BIOPSY VALVE CAME OPEN WHEN REMOVING A DEVICE CAUSING FLUID TO LEAK AND GOT ON TO A CAREGIVER'S FACE. AN IRRIGATION TO THE CAREGIVER'S EYES WAS DONE FOR 15 MINUTES. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT. THE CAREGIVER WAS REPORTED TO BE FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881413 ↗