Epix Inline Laparoscopic Scissors CB050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607915124519), received between Nov 9, 2016 and Jun 13, 2017 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Torn Material” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2017Torn Material; Torn Material

  PRE-OPERATION - SCISSOR REMOVED FROM PACKAGE AND UPON INSPECTION PRIOR TO CASE, THEY NOTICED A BREAK IN THE INSULATION ON THE DISTAL END OF THE SCISSOR. TYPE OF INTERVENTION - NA. PATIENT STATUS - NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639145 ↗
• MalfunctionMar 6, 2017Failure to Cut; Failure to Cut

  PROCEDURE PERFORMED UNKNOWN - "SCISSORS CUTTING DETERIORATED THROUGHOUT CASE WHERE MULTIPLE (5-6) FIBROIDS WHERE REMOVED. DR. FOX CONTINUED TO USE THEM UNTIL THEY FAILED TO CUT AT ALL. IT WAS A LONG CASE AND HE MADE MANY CUTS WITH MINIMAL USE OF THE CAUTERY." PATIENT STATUS - GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382350 ↗
• MalfunctionFeb 23, 2017Torn Material; Torn Material

  UNKNOWN PROCEDURE - "AFTER THE SCISSOR WAS OPENED THE PROTECTIVE SHEATH WAS REMOVED AND IN THE PROCESS THE INSULATION TORE." PATIENT STATUS - N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6353713 ↗
• MalfunctionJan 12, 2017Torn Material; Torn Material

  PROCEDURE PERFORMED UNKNOWN - "AFTER THE SCISSOR WAS OPENED THE PROTECTIVE SHEATH WAS REMOVED AND IN THE PROCESS THE INSULATION TORE." TYPE OF INTERVENTION - "USED THE PISTOL GRIP SCISSOR." PATIENT STATUS - "NA".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6246898 ↗
• MalfunctionJan 12, 2017Torn Material; Torn Material

  PROCEDURE PERFORMED UNKNOWN - "AFTER THE SCISSOR WAS OPENED THE PROTECTIVE SHEATH WAS REMOVED AND IN THE PROCESS THE INSULATION TORE." TYPE OF INTERVENTION - "USED THE PISTOL GRIP SCISSOR." PATIENT STATUS - "NA".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6246806 ↗
• MalfunctionJan 12, 2017Torn Material; Torn Material

  PROCEDURE PERFORMED UNKNOWN - "AFTER THE SCISSOR WAS OPENED THE PROTECTIVE SHEATH WAS REMOVED AND IN THE PROCESS THE INSULATION TORE." TYPE OF INTERVENTION - "USED THE PISTOL GRIP SCISSOR." PATIENT STATUS - "NA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6246667 ↗
• MalfunctionJan 4, 2017Output Problem; Output Problem

  DIAGNOSTIC LAPAROSCOPY - "THE MONOPOLAR ENERGY TRANSMISSION DELIVERED FROM THE SCISSOR TO THE PATIENT WAS INTERMITTENT. THEY REPLACED THE DEVICE AND IT WORKED FINE." PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6224024 ↗
• MalfunctionNov 9, 2016Melted; Overheating of Device; Melted; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED DECEMBER 7, 2016. "THE CLINICAL DEVELOPMENT TEAM VISITED (B)(6) SURGERY CENTER ON (B)(6) 2016 REGARDING (B)(4) (A CER REFERENCING INSULATION DAMAGE). IN DISCUSSIONS WITH THE SCRUB TECH, SHE COMMENTED THAT, IN HER OPINION, THE ROTATION KNOB HEATING UP (CER 2016-1035) WAS NOT A SERIOUS ISSUE AND THE CONCERNS FROM THE SURGEON WERE MOST LIKELY STEMMING FROM THE INCIDENT RELATED TO THE INSULATION DAMAGE FOR (B)(4)."

  Patient problems: Injury; Tissue Damage

  MAUDE report 6090034 ↗