NA VALLS1037Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551024952), received between Nov 1, 2018 and Nov 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Remains Activated” (1 report).

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

• MalfunctionNov 1, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE PERFORMED WITH A STERLIMED VESSEL SEALER "VESSEL SEALING INSTRUMENT LIGASURE ATLAS HAND ACTIVATED". DURING THE PROCEDURE THE PRODUCT KEPT ACTIVATING WITHOUT TOUCHING THE TRIGGER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE ISSUE OF THE VESSEL SEALER ACTIVATING WITHOUT TOUCHING THE TRIGGER WAS ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028721 ↗

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