PK TECHNOLOGY 3600PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925036093), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output below Specifications” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031078); 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.

• MalfunctionJul 26, 2022Output below Specifications; Output below Specifications

  OLYMPUS RECEIVED A MEDWATCH REPORT MW5110616 REPORTED THAT THE BIPOLAR MACRO FORCEPS WORKED ONLY VERY MINIMALLY AND DID NOT COAGULATE AS NEEDED. REPORTER NOTED ON THE FORM "OUTPUT BELOW SPECIFICATIONS. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031078. One submission often covers many models, so check the product and lot details in each record.

• Z-0100-2015 · Aug 27, 2014 · Terminated
  GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Fo