DUROTIP BC263RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04038653137817), received between Dec 7, 2020 and Oct 28, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2022Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT A TC METZENBAUM SCISSORS CVD 180MM (PART # BC263R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. AN X-RAY SCREENING WAS PERFORMED TO DETERMINE IF THE FRAGMENT DETACHED INTO THE PATIENT, BUT NOTHING WAS FOUND. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693765 ↗
• InjuryOct 21, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A TC METZENBAUM SCISSORS CVD 180MM (ITEM # BC263R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. AN X-RAY SCREENING WAS PERFORMED TO DETERMINE IF THE FRAGMENT DETACHED INTO THE PATIENT, BUT NOTHING WAS FOUND. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. HOWEVER, AN X-RAY WAS PERFORMED TO CONFIRM THAT NO FRAGMENT REMAINED IN THE PATIENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650820 ↗
• InjuryMay 6, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A TC METZENBAUM SCISSORS CVD 180MM (PART # BC263R) WAS USED DURING A SHOULDER REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF SCISSORS BROKE OFF. THE FRAGMENT WAS RECOVERED FROM THE PATIENT AND SCANS WERE PERFORMED TO CONFIRM THAT NO FRAGMENTS REMAINED. THE SCANS WERE NEGATIVE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THERE WAS A SURGICAL DELAY OF LESS THAN 5 MINUTES. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311529 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED TO AESCULAP INC. THAT A TC METZENBAUM SCISSORS CVD 180MM (PART # BC263R) WERE USED DURING A SHOULD REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE SCISSORS BROKE OFF. THE FRAGMENT WAS RECOVERED FROM THE PATIENT AND SCANS WERE PERFORMED TO CONFIRM THAT NO FRAGMENTS REMAINED. THE SCANS WERE NEGATIVE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280336 ↗
• InjuryDec 7, 2020Material Integrity Problem; Material Integrity Problem

  NO UPDATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960965 ↗