PK TECHNOLOGY 3103PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925036048), received between Aug 31, 2026 and Aug 31, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Deliver Energy” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K024286); 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.

• MalfunctionAug 31, 2026Failure to Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024286. One submission often covers many models, so check the product and lot details in each record.

• Z-0632-2010 · Aug 18, 2009 · Terminated
  Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.
• Z-0634-2010 · Aug 18, 2009 · Terminated
  Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.
• Z-0635-2010 · Aug 18, 2009 · Terminated
  Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 13
• Z-0637-2010 · Aug 18, 2009 · Terminated
  Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136
• Z-0633-2010 · Aug 18, 2009 · Terminated
  Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version
• Z-0636-2010 · Aug 18, 2009 · Terminated
  Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc.,