Direct Drive Reposable Scissors CB010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915117320), received between Mar 6, 2017 and Apr 4, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2017Torn Material; Torn Material

  LAP CHOLE - AS THEY OPENED THE PACKAGE, THE TIP OF THE BLADE END OF THE SCISSORS WAS RIPPED (SHEATH PART) AND LOOKED A LITTLE BIT BURNT. REP CONFIRMED WITH THE CUSTOMER THAT THE DEVICE WAS NOT RE-PROCESSED. TYPE OF INTERVENTION - NA. PATIENT INJURY - NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 6457223 ↗
• MalfunctionMar 6, 2017Failure to Cut; Failure to Cut

  LAPAROSCOPY - INCIDENT 1 - "WHEN ATTEMPTING TO CUT TISSUE, THE SCISSORS WOULD NOT CUT THROUGH. AN ADDITIONAL UNIT WAS OPENED FROM THE BOX AND THIS TOO WOULD NOT CUT EITHER. (B)(4). ALL REMAINING LOT NUMBER ON SHELF RETURNED." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382393 ↗
• MalfunctionMar 6, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED UNKNOWN - "ORIGINAL INCIDENT REPORT FORM WAS SUBMITTED BY (B)(6) AT (B)(6) WHO IS CURRENTLY ON SICK LEAVE. I HAVE BEEN UNABLE TO SPEAK TO (B)(6) ABOUT THE INCIDENT. ON THE REPORT SHE SUBMITTED TO HEALTH AUTHORITY, (B)(6) COMMENTED THAT THE SCISSOR INSERT WAS NOT ATTACHED TO SCISSOR TIP AND THAT IT HAD POTENTIAL TO BREAK APART INSIDE PATIENT. THE CUSTOMER HAS NOT RETAINED THE PRODUCT HOWEVER I HAVE RECEIVED PHOTOGRAPHS OF THE ITEM WHICH WILL BE ATTACHED ALONG WITH THIS FORM." PATIENT STATUS - UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382356 ↗
• MalfunctionMar 6, 2017Failure to Cut; Failure to Cut

  LAPAROSCOPY - INCIDENT 2 - "WHEN ATTEMPTING TO CUT TISSUE, THE SCISSOR WOULD NOT CUT THROUGH. THIS IS THE 2ND UNIT FROM SAME BATCH, SAME BOX. RETURNED ALL REMAINING LOT NO. OF PRODUCT. PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382348 ↗