Insert, Curved Scissors ES0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815288010996), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K191612, K912780); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Material Fragmentation; Off-Label Use; Material Fragmentation; Off-Label Use

  DURING A HYSTERECTOMY PROCEDURE, THE SURGEON WAS ATTEMPTING TO CUT A 0 V-LOC SUTURE WITH AN ENCISION ES0002 REUSABLE SCISSOR INSERT. THE SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. THE SCISSOR INSERT SLIPPED ON THE FIRST ATTEMPT TO CUT SUTURE. ON THE SECOND ATTEMPT TO CUT SUTURE, THE SCISSOR BROKE. THE FORCE OF THE CUT ATTEMPT, WHICH LED TO THE BREAKAGE, CAUSED THE SCISSOR BLADES TO SHOOT TO THE LEFT, MAKING THE INSERT UNUSABLE. THE SCISSOR BLADES AND HOUSING REMAINED ATTACHED TO THE HANDLE, INTO WHICH THE SCISSOR IS THREADED. HOWEVER, THE ROD PIN LIKELY SPLIT AND FELL OUT OF THE HOUSING INTO THE PATIENT. THE SURGEON AND THE TECHNICIAN HEARD AN AUDIBLE RATTLE DURING THE SUCTION OPERATION. AN AP AND LATERAL X-RAY WAS TAKEN FOLLOWING THE PROCEDURE. NO FOREIGN OBJECTS WERE FOUND IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191612, K912780. One submission often covers many models, so check the product and lot details in each record.

• Z-2396-2011 · Apr 7, 2011 · Terminated
  ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2399-2011 · Apr 7, 2011 · Terminated
  ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2400-2011 · Apr 7, 2011 · Terminated
  ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2395-2011 · Apr 7, 2011 · Terminated
  ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2398-2011 · Apr 7, 2011 · Terminated
  ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2397-2011 · Apr 7, 2011 · Terminated
  ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-1074-04 · Jun 11, 2004 · Terminated
  AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
• Z-0470-03 · Jan 15, 2003 · Terminated
  AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B