CoreDx™ M00515220Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 08714729971054), received between Aug 12, 2019 and Jul 20, 2026 — classified as 7 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (43 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Difficult to Open or Close

  It was reported to Boston Scientific Corporation that a CoreDx Pulmonary forceps was used during Bronchoscopy procedure on an unknown date.During the procedure, the forceps malfunctioned and could not be used to obtain a sample due to the jaws not closing once opened.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 Clinical Signs, Symptoms or Conditions

  MAUDE report 25884309 ↗
• MalfunctionJul 1, 2026Entrapment of Device; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX PULMONARY MINI BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FORCEPS BECAME STUCK IN THE OPEN POSITION AND COULD NOT BE CLOSED OR WITHDRAWN THROUGH THE ENDOSCOPE WORKING CHANNEL. AS A RESULT, THE FORCEPS AND ENDOSCOPE WERE REMOVED TOGETHER, AND THE DEVICE WAS CUT OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER COREDX DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682424 ↗
• InjuryMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX PULMONARY MINI BIOPSY FORCEPS WERE USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MINI FORCEPS BROKE OFF IN THE PULMONOLOGY SCOPE. THE PIECE THAT BROKE OFF WAS RETRIEVED WITH A NEW SCOPE. TWO SETS OF MINI FORCEPS BROKE WHILE INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WERE ANY REPORTED PATIENT COMPLICATION AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO COREDX PULMONARY MINI BIOPSY FORCEPS USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663061 ↗
• InjuryMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX PULMONARY MINI BIOPSY FORCEPS WERE USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MINI FORCEPS BROKE OFF IN THE PULMONOLOGY SCOPE. THE PIECE THAT BROKE OFF WAS RETRIEVED WITH A NEW SCOPE. TWO SETS OF MINI FORCEPS BROKE WHILE INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WERE ANY REPORTED PATIENT COMPLICATION AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COREDX PULMONARY MINI BIOPSY FORCEPS USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663019 ↗
• InjuryFeb 4, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX DEVICE WAS USED IN THE LUNGS DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE COREDX WAS INSERTED THROUGH THE PULMONOLOGY SCOPE INTO THE LUNG. HOWEVER, THE JAWS OF THE FORCEPS DETACHED AND FELL INTO THE PATIENT. THE DETACHED JAW WAS RETRIEVED WITH A NEW SCOPE. THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED LIFE-THREATENING HEMORRHAGE THAT WAS RESOLVED USING ADVANCED BRONCHOSCOPY TECHNIQUE AND ENDOBRONCHIAL MEDICATION. IT WAS REPORTED THAT THE HEMORRHAGE WAS LIKELY DEVELOPED DUE TO THE NATURE OF THE TUMOR BEING A VASCULAR CARCINOID ALONG WITH THE FORCEPS EFFECTIVELY SLICING THE PERIPHERAL EDGE OF THE TUMOR. FOLLOW-UP ATTEMPTS HAVE BEEN INITIATED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24264528 ↗
• MalfunctionJan 30, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX WAS UNPACKED FOR A BRONCHOSCOPY PROCEDURE ON (B)(6) 2026. DURING PREPARATION, THE PACKAGE WAS OPENED AND NURSE NOTICED A RED RESIDUE ON THE DISTAL END OF THE FORCEPS. THEY DECIDED TO OPEN ANOTHER PACKAGE THAT DID NOT HAVE THE SAME RESIDUE TO USE FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 30, 2026*** THE PACKAGING WAS SEALED AND THERE WAS NO OTHER EVIDENCE OF RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223403 ↗
• MalfunctionNov 20, 2025Entrapment of Device; Nonstandard Device; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Nonstandard Device; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX? WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE BIOPSY, THE CUP COULD NO LONGER BE OPENED OR CLOSED, AND THE DEVICE COULD NO LONGER BE REMOVED FROM THE FORCEPS CHANNEL OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED AS OF NOVEMBER 28, 2025: DURING A BRONCHOSCOPY FOR THE DIAGNOSIS OF A PATIENT WITH SUSPECTED LUNG CANCER, TWO ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURES WERE PERFORMED, FOLLOWED BY ONE ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL FORCEPS BIOPSY (EBUS-IFB) TO COLLECT TISSUE SAMPLES. THE JAWS OF THE FORCEPS WERE ABLE TO OPEN AND CLOSE INSIDE THE PATIENT. WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE FORCEPS FROM THE BRONCHOSCOPE AFTER CLOSING THEM AT THE LESION SITE IN PREPARATION FOR A REPEAT EBUS-IFB, THE FORCEPS BECAME STUCK AND COULD NOT BE REMOVED. THEY WERE ULTIMATELY WITHDRAWN TOGETHER WITH THE BRONCHOSCOPE. UPON INSPECTION, THE FORCEPS WERE FOUND TO BE DAMAGED, PROTRUDING FROM THE BRONCHOSCOPE'S FORCEPS CHANNEL, AND UNABLE TO CLOSE. TISSUE SAMPLES HAD BEEN COLLECTED, AND NO VISIBLY DETACHED P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607541 ↗
• MalfunctionOct 15, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX? WAS USED IN THE LUNG DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE CUP WAS OPENED AT THE TARGET SITE AND THE HANDLE WAS GRIPPED, THE JAWS FAILED TO CLOSE. THE PULL WIRE APPEARS TO HAVE BECOME SEPARATED. ANOTHER COREDX? WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293852 ↗
• MalfunctionSep 17, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX PULMONARY FORCEPS WAS USED IN THE LUNGS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED LYMPH NODE BIOPSY NEEDLE ASPIRATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE FORCEPS WERE OPENED, A WIRE POPPED OUT FROM THE INSIDE MAKING BIOPSY IMPOSSIBLE. THE PROCEDURE WAS COMPLETED USING ANOTHER COREDX PULMONARY FORCEPS. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076077 ↗
• MalfunctionSep 17, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX PULMONARY FORCEPS WAS USED IN THE LUNGS DURING A ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE FORCEPS WERE OPENED, THE WIRE PROTRUDES FROM THE INSIDE AND THE BIOPSY WAS UNABLE TO PERFORM. THE PROCEDURE WAS COMPLETED USING ANOTHER COREDX PULMONARY FORCEPS. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076005 ↗
• MalfunctionJul 21, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A COREDX BIOPSY FORCEPS WAS USED IN THE COMMON BILE DUCT DURING A PERCUTANEOUS CHOLANGIOSCOPY WITH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTED THAT THE JAWS OF THE FORCEPS WOULD NOT CLOSE. THE FORCEPS WERE REMOVED TOGETHER WITH THE SPYGLASS DISCOVERY SCOPE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560770 ↗
• MalfunctionJul 14, 2025Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE JAWS OF THE FORCEPS WAS FOUND STUCK IN AN OPEN POSITION AND UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 17, 2025. THE PROCEDURE WAS COMPLETED WITH ANOTHER COREDX FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500840 ↗
• MalfunctionJun 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX? WAS USED IN THE LUNGS DURING A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DAY IN (B)(6) 2025. DURING THE PROCEDURE, THE JAWS WERE OPENED INSIDE THE LUNG NODULE BUT COULD NOT BE CLOSED TO OBTAIN BIOPSY. THE BRONCHOSCOPE WAS ADVANCED SLIGHTLY, BUT THE JAWS WERE STILL UNABLE TO CLOSE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209326 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE AIRWAY DURING A BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, ONE SIDE OF BIOPSY FORCEP POPPED OFF DURING CASE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573484 ↗
• MalfunctionSep 16, 2024Break; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS ATTEMPTED TO BE USED IN THE PULMONARY SUBMUCOSAL LYMPH NODES DURING AN ENDOSCOPIC ULTRASOUND-GUIDED LYMPH NODE BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE FOR OPENING AND CLOSING THE CUP WAS DETACHED MAKING IT IMPOSSIBLE TO OPEN AND CLOSE. WHEN THE HANDLE WAS OPERATED, THE WIRE TIP WOULD ONLY PROTRUDE OR RETRACT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224618 ↗
• MalfunctionJul 26, 2024Difficult to Open or Close; Difficult to Open or Close

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COREDX BIOPSY FORCEPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, TWO FORCEPS WERE STUCK IN OPEN POSITION AND WERE UNABLE TO CLOSE WITH THE HANDLE. THE FIRST BIOPSY FORCEPS FAILED TO CLOSE AFTER FIRST SAMPLE AND THE SECOND FORCEPS FAILED TO CLOSE AFTER FOUR SAMPLE ATTEMPTS. NO FURTHER INFORMATION OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839248 ↗
• MalfunctionJul 26, 2024Difficult to Open or Close; Difficult to Open or Close

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO COREDX BIOPSY FORCEPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, TWO FORCEPS WERE STUCK IN OPEN POSITION AND WERE UNABLE TO CLOSE WITH THE HANDLE. THE FIRST BIOPSY FORCEPS FAILED TO CLOSE AFTER FIRST SAMPLE AND THE SECOND FORCEPS FAILED TO CLOSE AFTER FOUR SAMPLE ATTEMPTS. NO FURTHER INFORMATION OBTAINED DESPITE GOOD FAITH EFFORTS. ***INFORMATION RECEIVED ON JULY 26, 2024*** INFORMATION WAS RECEIVED THAT THIS EVENT IS A DUPLICATE. SEE MFR. REPORT #3005099803-2024-03020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838194 ↗
• MalfunctionJun 28, 2024Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DIFFERENT CORE DX DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LN7 DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE CUPS FAILED TO CLOSE AND HAD UNEVEN OPENING. A SECOND COREDX BIOPSY FORCEPS WAS TRIED AND THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD COREDX BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO AND VIDEO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED SHOWING THE JAWS WITH UNEVEN OPENING AND FAILING TO CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633247 ↗
• MalfunctionJun 28, 2024Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DIFFERENT CORE DX DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LN7 DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE CUPS FAILED TO CLOSE AND HAD UNEVEN OPENING. A SECOND COREDX BIOPSY FORCEPS WAS TRIED AND THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD COREDX BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO AND VIDEO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED SHOWING THE JAWS WITH UNEVEN OPENING AND FAILING TO CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633222 ↗
• MalfunctionJun 27, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, THE CUPS FAILED TO CLOSE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627554 ↗
• MalfunctionJun 27, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUPS FAILED TO CLOSE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627315 ↗
• MalfunctionJun 21, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LYMPH NODE OF THE LUNGS DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING INSERTION, WHEN ACTUATING THE HANDLE, A CRACKING SOUND WAS NOTED, AND THE CUPS COULD NO LONGER CLOSE. ANOTHER COREDX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587270 ↗
• MalfunctionApr 3, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX WAS USED IN THE RIGHT UPPER LOBE OF THE LUNGS DURING AN INTRANODAL BIOPSY PROCEDURE PERFORMED ON (B)(6)2024. DURING THE PROCEDURE, THE JAWS OF THE FORCEPS BECAME STUCK IN AN OPEN POSITION AND WAS UNABLE TO CLOSE. AS A RESULT, THE FORCEPS WAS UNABLE TO RETRACT BACK THROUGH THE SCOPE CHANNEL. THE ENTIRE SCOPE WAS PULLED OUT WITH THE FORCEPS. THE END OF THE FORCEPS WAS THEN CUT WITH A TOOL AND THEN WAS ABLE TO PULL THE REMAINDER OF THE FORCEPS OUT OF THE SCOPE. A NON-BOSTON SCIENTIFIC PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033208 ↗
• MalfunctionApr 1, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX WAS USED IN THE LUNG DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE JAWS OF THE COREDX DEVICE WERE UNABLE TO CLOSE AND PREVENTED THE FORCEPS FROM BEING WITHDRAWN BACK THROUGH THE SCOPE CHANNEL. AS A RESULT, THE ENTIRE SCOPE WITH THE FORCEPS WAS PULLED OUT. THE END OF THE FORCEPS WAS THEN CUT, WHICH ALLOWED THE REMAINDER OF THE FORCEPS TO BE PULLED OUT OF THE SCOPE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011249 ↗
• MalfunctionDec 29, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE JAWS OF THE FORCEPS WAS UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418561 ↗