NA AUT176643Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551013017), received between Jan 4, 2023 and Jan 4, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K012598); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH TWO ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES. DEVICE WAS POKING OUT OF THE BAG AND NO LONGER STERILE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE POUCH HAD A HOLE IN IT AND THE TIP OF THE DEVICE WAS POKING OUT OF IT. NO FOREIGN MATERIAL OR SPOT OBSERVED ON THE DEVICE. THE DAMAGE COULD BE RELATED TO SHIPPING OR HANDLING. THE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093177 ↗
• MalfunctionJan 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH TWO ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES. DEVICE WAS POKING OUT OF THE BAG AND NO LONGER STERILE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE POUCH HAD A HOLE IN IT AND THE TIP OF THE DEVICE WAS POKING OUT OF IT. NO FOREIGN MATERIAL OR SPOT OBSERVED ON THE DEVICE. THE DAMAGE COULD BE RELATED TO SHIPPING OR HANDLING. THE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE ENDO SHEARS WITH UNIPOLAR CAUTERY FOR STERILITY INTEGRITY COMPROMISED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093176 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012598. One submission often covers many models, so check the product and lot details in each record.

• Z-0560-2009 · Aug 8, 2008 · Terminated
  Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK Laparosc