Cellebrity M00516150Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729746331), received between Dec 27, 2018 and Aug 27, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Unsealed Device Packaging

  It was reported to Boston Scientific Corporation that a Cellebrity was to be used during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026.During preparation, the device was opened and the seal was missing from the packaging. The procedure was completed with another device of the same model. There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484060 ↗
• MalfunctionSep 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED IN A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THEY PULLED THE BRUSH OUT OF THE SCOPE THE INTERNAL WIRE STAYED IN THE SCOPE AND THE PATIENT. A PHOTO OF THE DEVICE WAS PROVIDED SHOWING THE WORKING LENGTH DETACHED. THE BRUSH WAS REMOVED BY PULLING THE WIRE STICKING OUT OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125996 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY PULMONARY CYTOLOGY BRUSH WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE BROKE WITHIN THE CATHETER NEAR THE BRUSH PORTION. THE BRUSH DID NOT COMPLETELY DETACH. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268699 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Retraction Problem; Detachment of Device or Device Component; Mechanical Problem; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CELLEBRITY CYTOLOGY BRUSHES WERE PREPARED FOR USE PRIOR TO DIAGNOSING THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE AND OUTSIDE THE PATIENT, THEY SAID THAT THE BRUSHES WERE NOT EXTENDING OR RETRACTING CORRECTLY. THEY CAME THIS WAY OUT OF THE BOX AND NEITHER ONE OF THEM WERE USED ON ANY PATIENTS. REPORTEDLY, NO VISIBLE ISSUES WERE NOTED WITH THE HANDLES OF THESE BRUSHES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE WORKING LENGTH (SHEATH) WAS DETACHED FROM THE HANDLE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE INVESTIGATION RESULTS WHICH REVEALED THAT THE YELLOW SHEATHING WAS DETACHED AT THE HANDLE, IT WAS DETERMINED THAT THE MEDICAL DEVICE REPORT (MDR) WAS SENT IN ERROR. DETACHMENT OF THE SHEA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310482 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295193 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295178 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295173 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295171 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295147 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295139 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295138 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295110 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295108 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 AND 3005099803-2020-02815 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT LEAST TEN CELLEBRITY CYTOLOGY BRUSHES WERE OPENED AND USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE IT MEETS THE HANDLE. WHEN THE CATHETER SLID DISTALLY DOWN TOWARDS THE BRISTLED PORTION OF THE BRUSH, IT PREVENTED THE BRUSH FROM EXTENDING AND WORKING PROPERLY. REPORTEDLY, IT COVERED THE BRUSH WHEN THE HANDLE WAS FULLY OPEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO FINE. UPDATE BASED ON REVIEW SEPTEMBER 01, 2020. NOTE: BASED ON FURTHER REVIEW OF THE EVENT, "YELLOW SHEATHING THAT HOUSED THE BRUSH WAS COMING OFF WHERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295107 ↗
• MalfunctionOct 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY PULMONARY CYTOLOGY BRUSH WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER TWO PASSES OF OPENING AND CLOSING, THE SHEATH OF THE BRUSH GOT BROKEN. THE WIRE POPPED OUT OF THE SHEATH FROM THE TOP AND THEY HAD TO STRIP THE SHEATH TO GET THE BRUSH OUT FOR THE SAMPLES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF 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 9233471 ↗
• MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY PULLED THE PRODUCT OUT OF THE PACKAGE AND UPON INSERTION, THE BRUSH WAS DETACHED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738967 ↗
• MalfunctionDec 27, 2018Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BRUSH WAS INSERTED INTO THE SCOPE, IT WAS NOTED THAT THE PULL WIRE WAS BROKEN AND PUNCTURED THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199552 ↗