SpyBite Max M00546470Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729996699), received between Feb 9, 2022 and May 7, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX BIOPSY FORCEPS WAS USED IN THE COMMON BILE DUCT FOR CHOLANGITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SINGLE-OPERATOR CHOLANGIOSCOPY (SOC) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE COULD NOT REACH THE DESIRED AREA. THE HOLMIUM LASER FIBER AND SPYBITE FORCEPS COULD NOT BE INSERTED INTO THE SPYGLASS CATHETER. AS A RESULT, THE PROCEDURE WAS CANCELLED AND NOT COMPLETED. THE PATIENT WAS NOT RESCHEDULED FOR ANOTHER SURGERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116564 ↗
• MalfunctionOct 17, 2025Difficult to Advance; Difficult to Open or Close; Difficult to Advance; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX WAS USED IN THE HILAR DURING A BIOPSY ON (B)(6) 2025. DURING THE PROCEDURE, THE SPYBITE MAX CANNOT BE OPENED AT DESIRED LOCATION AND THERE WAS RESISTANCE WHEN THE PHYSICIAN INSERTS THE DEVICE THROUGH THE WORKING CHANNEL. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320214 ↗
• MalfunctionJun 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEP WAS USED IN THE HEPATIC BILE DUCT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) WITH THE SPYGLASS PROCEDURE FOR A BIOPSY ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE SPYBITE BIOPSY FORCEP WAS INSERTED AND OPENED, THE DEVICE DID NOT CLOSE TO TAKE A BIOPSY SAMPLE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328075 ↗
• MalfunctionMay 5, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS USED IN THE DISTAL COMMON BILE DUCT DURING A SINGLE OPERATED CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, SPYBITE WAS USED TO OBTAIN THE TISSUE SAMPLE, HOWEVER, IT WAS IMPOSSIBLE TO PASS THROUGH THE SPYGLASS CATHETER. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958675 ↗
• MalfunctionApr 30, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS USED IN THE LEFT HEPATIC DUCT DURING A SINGLE OPERATED CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SPYBITE COULDN'T APPROACH TO THE TARGETED AREA IN THE LEFT HEPATIC DUCT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934941 ↗
• MalfunctionMar 20, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX WAS USED IN THE COMMON BILE DUCT DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, WHILE TAKING SAMPLES USING THE SPYBITE MAX, ONE OF THE JAWS WOULD NOT CLOSE. THE ENTIRE SPYGLASS DEVICE WAS TAKEN OUT TO REMOVE THE FORCEPS. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651992 ↗
• MalfunctionJan 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEP WAS USED IN THE COMMON BILE DUCT DURING A BIOPSY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, SPYBITE MAX BIOPSY FORCEP CANNOT BE OPENED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126680 ↗
• InjuryJul 12, 2024Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-03260 FOR THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND 3005099803-2024-03292 FOR THE SPYBITE BIOPSY FORCEP. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX BIOPSY FORCEPS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF ERCP STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN USED A TOME AND WIRE TO ACCESS THE SITE. ONCE THE SITE WAS ACCESSED, THEY NOTICED THAT THEY COULD NOT GET THROUGH THE BIFURCATION. THE PHYSICIAN INTRODUCED THE SPYSCOPE TO GET A BETTER VISUAL AND OBSERVED WHAT LOOKED LIKE A MALIGNANT WALL. BUBBLES WERE SUCTIONED OUT VIA SYRINGE TO CLEAR THE VIEW. THEY THEN INSERTED A SPYBITE BIOPSY FORCEP DOWN THE SCOPES CHANNEL. AFTER SOME DIFFICULTY GETTING THE SPYBITE THROUGH THE CURVED POSITION OF THE SCOPE, THEY CANNULATED AND TOOK A BIOPSY. THE FORCEPS WERE THEN REMOVED AND INSERTED AGAIN TO OBTAIN ANOTHER BIOPSY. THE PATIENT BEGAN TO CRASH, THE SCOPE WAS REMOVED, AND A CODE BLUE WAS CALLED. CARDIOPULMONARY RESUSCITATION (CPR)

  Patient problems: Cardiac Arrest

  MAUDE report 19735367 ↗
• MalfunctionJun 4, 2024Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX BIOPSY FORCEPS WAS USED IN THE PANCREATIC DUCT DURING A STONE CRUSHING / LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER CRUSHING THE PANCREATIC STONE WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL), RESISTANCE WAS NOTED IN INSERTING THE SPYBITE MAX INTO THE SPY DS II SCOPE. THE FORCEPS WAS EVENTUALLY INSERTED; HOWEVER, THE SPY DS II SCOPE COULD NOT DISPLAY THE IMAGES. AS A RESULT, THE JAWS COULD NOT OPEN TO RETRIEVE THE STONE. ANOTHER ATTEMPT TO RETRIEVE THE STONE BY USING THE SPYBITE MAX WITH THE SPY DS II SCOPE WAS UNSUCCESSFUL, AS THE JAWS FAILED TO OPEN, MAKING IT UNUSABLE. ADDITIONALLY, THE WORKING LENGTH WAS KINKED. THE PROCEDURE WAS ABORTED AS A REPLACEMENT DEVICE WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462085 ↗
• MalfunctionJan 2, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEP WAS USED IN THE COMMON BILE DUCT ON AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE FORCEPS COULD NOT BE REMOVED FROM THE ENDOSCOPE AND WERE TWISTED, MAKING IT UNUSABLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427543 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND SPYBITE MAX BIOPSY FORCEPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED ALONG WITH A SPYBITE MAX BIOPSY FORCEPS DURING AN ENDOSCOPIC BILE DUCT BIOPSY PROCEDURE PERFORMED FOR THE TREATMENT OF SUSPECTED INTRAHEPATIC BILE DUCT CANCER ON (B)(6) 2023. DURING THE PROCEDURE, THE PATIENT WAS SCHEDULED FOR A BIOPSY AND A SPECIMEN WAS COLLECTED FROM THE DISTAL BILE DUCT. WHEN IT WAS ABOUT TO REACH THE TARGET PORTA HEPATIS, THE IMAGE OF THE SPYSCOPE DS II BECAME DISTORTED AND WAS LOST AFTER ONE HOUR OF USAGE. A SECOND SPYSCOPE DS II WAS USED, AND THEY NOTICED A BILE DUCT PERFORATION. THEY WERE UNABLE TO COLLECT THE SPECIMEN AND MADE A PATHOLOGICAL DIAGNOSIS. ANY FORCEFUL OR PROLONGED OPERATIONS USING THE DEVICE WAS NOT PERFORMED AFTER TWO REPEATED INSERTIONS AND REMOVALS. A SURGICAL INTERVENTION WAS THEN PERFORMED; THE PHYSICIAN BELIEVED THAT THE PERFORATION WAS NOT CAUSE BY THE SPYSCOPE DS II, BUT DUE TO THE PROCEDURAL PROBLEMS THAT WERE PERFORMED (ENDOSCOPIC SPHINCTEROTOMY, ENDOSCOPIC PAPILLARY BALLOON DILATATION AND ENDOSCOPIC PAPILLARY LARGE BALL

  Patient problems: Perforation

  MAUDE report 18092412 ↗
• MalfunctionApr 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX BIOPSY FORCEPS WAS USED DURING AN E.R.C.P. (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, AFTER THE PATIENT HAD BEEN SEDATED, WHEN DEVICE WAS UNPACKED, IT WAS NOTICED THAT THE SHEATH OF THE SPYBITE FORCEPS WAS KINKED. HOWEVER, THE PROCEDURE WAS CANCELLED DUE TO THE PATIENT BEING WEAK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693742 ↗
• MalfunctionDec 23, 2022Break; Use of Device Problem; Difficult to Open or Close; Break; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE FORCEPS FAILED TO CLOSE, AND THE PULL WIRE PROTRUDED OUT THE CENTER. ANOTHER SPYBITE BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE SPYBITE BIOPSY FORCEPS WAS USED IN A ROBOTIC BRONCHOSCOPY PROCEDURE. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) "THE SPYBITE BIOPSY FORCEPS SHOULD ONLY BE USED BY OR UNDER THE SUPERVISION OF PHYSICIANS TRAINED IN ENDOSCOPIC BILIARY AND PANCREATIC DUCTS EXPLORATION. A THOROUGH UNDERSTANDING OF THE TECHNICAL PRINCIPLES, CLINICAL APPLICATIONS AND RISKS ASSOCIATED WITH THE EXPLORATION OF THE BILIARY AND PANCREATIC DUCTS ARE NECESSARY BEFORE USING THIS DEVICE." THE DEVICE IS NOT INDICATED FOR USE IN THE LUNGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042142 ↗
• MalfunctionNov 23, 2022Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FORCEPS FAILED TO CLOSE. THE PHYSICIAN MANAGED TO PULL THE FORCEPS OUT AND ANOTHER SPYBITE BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE SPYBITE BIOPSY FORCEPS WAS USED IN A ROBOTIC BRONCHOSCOPY PROCEDURE. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) "THE SPYBITE BIOPSY FORCEPS SHOULD ONLY BE USED BY OR UNDER THE SUPERVISION OF PHYSICIANS TRAINED IN ENDOSCOPIC BILIARY AND PANCREATIC DUCTS EXPLORATION. A THOROUGH UNDERSTANDING OF THE TECHNICAL PRINCIPLES, CLINICAL APPLICATIONS AND RISKS ASSOCIATED WITH THE EXPLORATION OF THE BILIARY AND PANCREATIC DUCTS ARE NECESSARY BEFORE USING THIS DEVICE." THE DEVICE IS NOT INDICATED FOR USE IN THE LUNGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850067 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE MAX BIOPSY FORCEPS WAS USED IN THE BILIARY TRACT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) PROCEDURE PERFORMED ON (B)(6), 2021. ON (B)(6), 2021, ONE BILIARY DRAINAGE WAS IMPLANTED INTO THE PATIENT. ON (B)(6), 2021, A GUIDEWIRE ASSISTED SPYGLASS DISCOVER DIGITAL CATHETER WAS ADVANCED TO THE BILIARY STRICTURE AND THE TARGET LESIONS OR STONES WERE VISUALIZED WITH A SPYGLASS DIGITAL SYSTEM. A SPYBITE MAX BIOPSY FORCEPS WAS ALSO USED DURING THE STUDY. ON (B)(6), 2022, HEMOBILIA WAS NOTED. THE PATIENT WAS TREATED WITH AN ANTIBIOTIC AND SALINE SOLUTION. THE TREATMENT WAS RESOLVED AND STOPPED ON (B)(6), 2022. ON (B)(6), 2022, THE PATIENT DEVELOPED FEVER AND DYSPNEA, DUE TO THE APPEARANCE OF A HEPATIC COLLECTION. PATIENT HOSPITALIZED ON (B)(6), 2022 WHERE DRAINAGE OF THE COLLECTION WAS PERFORMED, WITH ANTIBIOTICS AND TWO BLOOD TRANSFUSIONS GIVEN. REPORTEDLY, THE PATIENT UNDERGONE HEPATIC EMBOLIZATION ON (B)(6), 2021, THE DAY AFTER PTCS PROCEDURE WAS PERFORMED. ***ADDITIONAL INFORMATION RECEIVED AS OF APRIL 07, 2022*** THE ADVERSE EVENT OF FEVER AND DYSPNEA ARE CONFIRMED TO BE SYMPTOMS OF SEPSIS AND CHOLANGITIS.

  Patient problems: Dyspnea; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation; Sepsis

  MAUDE report 13496817 ↗