Cellebrity M00516010Recalls & reported problems
Boston Scientific Corporation · Endoscopic Cytology Brush · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729746249), received between Jul 5, 2017 and Jan 29, 2025 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Mechanical Problem3
- Bent2
- Break1
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding2
- Perforation2
- Pneumothorax2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Detachment 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) 2024. DURING THE PROCEDURE, THE SHEATH PULLED OFF THE WIRE AND BRUSH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON JANUARY 21, 2025*** THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21266145 ↗MalfunctionAug 22, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY BRUSH WAS USED DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. BEFORE THE DEVICE COULD BE USED, THE BRUSH WOULD NOT DEPLOY. THE YELLOW TUBING WAS BROKEN OFF. THE PROCEDURE WAS REPORTED TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031739 ↗InjuryAug 22, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04035 FOR THE FIRST CELLEBRITY BIOPSY BRUSH AND 3005099803-2024-03937 FOR THE SECOND CELLEBRITY BIOPSY BRUSH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY BRUSH WAS USED DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN DEPLOYING THE BRUSH, THE SHEATH BROKE OFF AT THE HANDLE AND WENT FORWARD INTO THE PATIENT, PUNCTURING THE LUNG. THE PATIENT EXPERIENCED BLEEDING AND A PNEUMOTHORAX. COLD SALINE WAS APPLIED, AND A CHEST TUBE WAS PLACED. A SECOND BRUSH WAS USED AND BROKE WHEN THE BRUSH WAS PUT ON THE MICROSCOPE SLIDE. THE PROCEDURE WAS REPORTED TO BE COMPLETED. THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE DUE TO THIS EVENT AND WAS REPORTED TO HAVE FULLY RECOVERED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 20, 2024. IT WAS REPORTED THAT THE SECOND CELLEBRITY USED FAILED TO EXTEND THE BRUSH PRIOR TO BEING USED IN THE PROCEDURE. A THIRD BRUSH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Perforation; Pneumothorax
MAUDE report 20025161 ↗InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04035 FOR THE FIRST CELLEBRITY BIOPSY BRUSH AND 3005099803-2024-03937 FOR THE SECOND CELLEBRITY BIOPSY BRUSH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY BRUSH WAS USED DURING A ROBOTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN DEPLOYING THE BRUSH, THE SHEATH BROKE OFF AT THE HANDLE AND WENT FORWARD INTO THE PATIENT, PUNCTURING THE LUNG. THE PATIENT EXPERIENCED BLEEDING AND A PNEUMOTHORAX. COLD SALINE WAS APPLIED, AND A CHEST TUBE WAS PLACED. A SECOND BRUSH WAS USED AND BROKE WHEN THE BRUSH WAS PUT ON THE MICROSCOPE SLIDE. THE PROCEDURE WAS REPORTED TO BE COMPLETED. THE PATIENT WAS HOSPITALIZED BEYOND THE STANDARD OF CARE DUE TO THIS EVENT AND WAS REPORTED TO HAVE FULLY RECOVERED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 20, 2024. IT WAS REPORTED THAT THE SECOND CELLEBRITY USED FAILED TO EXTEND THE BRUSH PRIOR TO BEING USED IN THE PROCEDURE. A THIRD BRUSH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Pneumothorax
MAUDE report 20023761 ↗MalfunctionDec 2, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY PULMONARY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH BRONCHIAL BRUSHINGS PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH WAS ABLE TO EXTEND FROM THE SHEATH TO TAKE TISSUE SAMPLES. HOWEVER, THE BRUSH FAILED TO EXTEND WHEN THEY TRIED TO PUT THE SPECIMEN IN THE JAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER PULMONARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. 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 WHEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9398674 ↗MalfunctionOct 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE NURSE TRIED TO OPEN THE CYTOLOGY BRUSH BUT THE PULL WIRE WAS BROKEN JUST BELOW THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PULMONARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE WORKING LENGTH (SHEATH AND WIRE) WAS FOUND BROKEN FROM THE HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9146457 ↗MalfunctionApr 20, 2018Bent; Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH BRUSHING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH WAS BENT. IT WAS NOTICED THAT THE DEVICE WAS DIFFICULT TO ADVANCE AND RETRACT THROUGH THE WORKING CHANNEL OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY CYTOLOGY BRUSH. 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 BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7449153 ↗MalfunctionApr 17, 2018Bent; Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY WITH BRUSHING PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH WAS BENT AND IT WAS NOTICED THAT THE DEVICE WAS DIFFICULT TO ADVANCE THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7436223 ↗MalfunctionDec 6, 2017Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER WAS KINKED AND THE BRUSH FAILED TO EXTEND AND RETRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELEBRITY CYTOLOGY BRUSH. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; WIRE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7087270 ↗MalfunctionJul 5, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELLEBRITY CYTOLOGY BRUSH WAS OPENED FOR USE DURING A CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE CATHETER WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY CYTOLOGY BRUSH. 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 BE GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6687101 ↗
Other BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) devices
- Cellebrity M00516150Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)17 reports
- CONMED 130Conmed Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)4 reports
- Cellebrity M00516070Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)3 reports
- Cellebrity M00516000Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1500Covidien LP · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1000Covidien LP · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1000Covidien LP · Brush, biopsy, bronchoscope (non-rigid)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.