SpyBite M00546270Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729764458), received between Oct 12, 2017 and May 19, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS USED IN THE WIRSUNG PANCREAS DURING AN EXPLORATION WITH DISCOVER SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE FORCEPS FAILED TO CLOSE ON THE FOURTH SAMPLE ATTEMPT. THE CATHETER WAS CUT, AND THE FORCEPS WERE REMOVED FROM THE WORKING CHANNEL OF THE SCOPE. THE FORCEPS DID NOT COLLECT A SUFFICIENT SAMPLE AND THERE WERE NO MORE BIOPSY FORCEPS AVAILABLE; THEREFORE, THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16967298 ↗
• MalfunctionSep 22, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CLAMP OF THE SPYBITE BIOPSY FORCEPS WAS BROKEN AND MADE IT IMPOSSIBLE FOR THE PHYSICIAN TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10566583 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II, SPYBITE, AND JAGWIRE USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-00067 AND 3005099803-2020-00068 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II, SPYBITE, JAGWIRE REVOLUTION AND A NON-BSC SPHINCTEROTOME WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT SUFFERED AN AIR EMBOLISM WHICH WAS SUSPECTED TO BE CAUSED BY A PERFORATION. THE PHYSICIAN COULD NOT CONFIRM IF THE PERFORATION WAS RELATED TO THE SPYSCOPE, SPYBITE, GUIDEWIRE, OR NON-BSC SPHINCTEROTOME. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE PERFORATION TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Air Embolism; Perforation

  MAUDE report 9595706 ↗
• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01800 FOR THE SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER, AND 3005099803-2018-01801 FOR THE SPYBITE¿ BIOPSY FORCEPS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS & DELIVERY CATHETER AND A SPYBITE¿ WERE USED IN THE COMMON BILE DUCT (CBD) DURING A BILE DUCT BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THEY PERFORMED BILE DUCT BIOPSY USING THESE DEVICES. ON (B)(6) 2018, AN ENDOSCOPY CONFIRMED THAT THE PATIENT WAS BLEEDING AND AFTERWARDS THE PATIENT EXPERIENCED SEVERE PAIN. A NON-BSC COVERED STENT WAS USED TO STOP THE BLEEDING BUT IT PERFORATED THE BILE DUCT, AND PART OF THE STENT PROTRUDED INTO THE ABDOMINAL CAVITY. THE BLEEDING WAS NOT STOPPED. THEY USED A HARDENER AND A METAL COIL DURING ANGIOGRAPHY AND THE BLEEDING WAS STOPPED. THE STENT REMAINED INSIDE THE PATIENT AND AN ENDOSCOPIC REMOVAL PROCEDURE IS PLANNED. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT HAD LIVER CIRRHOSIS AND THEN DURING USE, THE DEVICES SCRUBBED THE BILE DUCT NEAR DUODENAL PAPILLA. ANEURYSM HAD DEVELOPED AND BLEEDING OCCUR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 7548686 ↗
• MalfunctionOct 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-03052 FOR THE FIRST SPYBITE BIOPSY FORCEPS, AND 3005099803-2017-03053 FOR THE SECOND SPYBITE BIOPSY FORCEPS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE "SEEMED TO BE BILE AND DIRT WAS NOTICED." THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT. 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.

  Patient problems: No Patient Involvement

  MAUDE report 6945332 ↗
• MalfunctionOct 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-03052 FOR THE FIRST SPYBITE BIOPSY FORCEPS, AND 3005099803-2017-03053 FOR THE SECOND SPYBITE BIOPSY FORCEPS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE "SEEMED TO BE BILE AND DIRT WAS NOTICED." THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT. 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.

  Patient problems: No Patient Involvement

  MAUDE report 6945330 ↗