OLYMPUS 3700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925035928), received between Jun 7, 2022 and Apr 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031080); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE DISSECTOR WAS OPEN AND OBSERVED TO HAVE A DEFORMATION ON THE JAW TIP UNDER LAPAROSCOPIC VIEW. THE EVENT OCCURRED AT THE BEGINNING OF A THERAPEUTIC LAPAROTOMY. THE FORCEPS WERE DRAWN OUT AND REPLACED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686536 ↗
• MalfunctionMar 10, 2023Energy Output Problem; Output Problem; Energy Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS REPRESENTATIVE THAT THE 3700 DISSECTOR WOULD NOT CAUTERIZE USING BIPOLAR. THE ISSUE OCCURRED DURING A THERAPEUTIC LAP TUBAL LIGATION PROCEDURE. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT WORK, TRIED A DIFFERENT BIPOLAR CORD AND STILL WOULD NOT WORK. PER THE REPORTER, THE PROCEDURE WAS PROLONGED, (DID NOT SPECIFY HOW LONG), DUE TO THEY TRIED DIFFERENT CORD FOR THE DEVICE. A NEW DEVICE WAS OPENED WITH SAME CORD AND IT WORKED. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO OTHER DEVICE CONNECTED TO THE SUBJECT DEVICE WHEN THE FAILURE OCCURRED. NO IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. NO HARM OR INJURY WAS REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519589 ↗
• MalfunctionJun 7, 2022Break; Break

  AS REPORTED, DURING A BSO (BILATERIAL SALPINGO OOPHERECTOMY) THERAPEUTIC PROCEDURE, THE SURGEON WAS DISSECTING SOFT FATTY TISSUE WHEN THE JAW TIP BROKE OFF. THE SURGEON COULD NOT FIND AND COULD NOT RETRIEVE THE BROKEN PIECE IN THE ABDOMINAL CAVITY. ACCORDING TO REPORTER, " THE SURGEON (GENERAL SURGEON) WAS PERFORMING A BSO ON THE PATIENT. WHILE DISSECTING SOFT FATTY TISSUE THE TIP OF THE JAW BROKE OFF CLEAN. THE EVENT WAS DETECTED WHEN THE SURGEON WANTED TO CONTINUE DISSECTING. THE BROKEN JAW PIECE WAS LEFT BEHIND IN THE ABDOMINAL CAVITY". ACCORDING TO THE REPORTER " SURGEON DID NOT RETRIEVE THE TIP AS THE POTENTIAL ADVERSE SIDE EFFECT WOULD BE GREATER THAN LEAVING THE BLUNT AND STERILE TIP BEHIND". THERE WAS NO PATIENT HARM OR INJURY REPORTED ,NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14614798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031080. One submission often covers many models, so check the product and lot details in each record.

• Z-1983-2013 · Jul 24, 2013 · Terminated
  GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO.