Insert, Wave Grasper ES0537Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815288011733), received between Oct 15, 2019 and Nov 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2019Device Fell

  "THE CUSTOMER STATED THAT PART OF THE TIP FELL INTO THE PATIENT, BUT IT DOES NOT APPEAR THAT A MATERIAL FRAGMENT IS MISSING."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9287803 ↗
• MalfunctionOct 15, 2019Break

  CUSTOMER REPORTED DURING LAPAROSCOPIC CHOLECYSTECTOMY THAT INCISION ES0537 WAVE GRASPER INSERT BROKE AT THE BASE OF THE JAW NEAR THE HINGE. CUSTOMER REPORTED NO SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED. CUSTOMER REPORTED NO RISK OF SERIOUS INJURY OR DEATH IF THE EVENT REOCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9195086 ↗

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-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-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-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-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-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-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-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