Olympus A60201ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761009799), received between Jan 14, 2019 and May 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• InjuryMay 11, 2023Material Separation; Material Deformation; Material Separation; Material Deformation

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE USING THE JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI, IT BECAME IMPOSSIBLE TO GRASP. "ABNORMAL NOISE" WAS REPORTED. THE SHAFT OF THE UNIT SEPARATED FROM THE MOVING PART OF THE JAW, AND DID NOT INTERLOCK WITH THE HANDLE OPERATION. IT WAS STATED THAT "FRACTURE SURFACE" WAS NOT VISIBLE AND DEFORMATION OF THE COMBINED SHEATHS WAS CONFIRMED. THE PROCEDURE WAS COMPLETED BY REPLACING THE EQUIPMENT WITH SIMILAR EQUIPMENT. IT WAS ALSO STATED THAT THE AT THE TIME OF THE REPORT, THE HOSPITAL COULD NOT CONFIRM THE PARTS HAD NOT BEEN RETAINED IN THE PATIENT, AND IT WAS BEING TREATED AS IF THE DEVICES HAD FALLEN INTO A BODY CAVITY. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES, BUT WAS NOT RECEIVED. THIS EVENT INVOLVED 3 DEVICES. PATIENT IDENTIFIER (B)(6) IS FOR THE JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI PATIENT IDENTIFIER (B)(6) IS FOR THE SHAFT "HIQ+", 5 X 330 MM PATIENT IDENTIFIER (B)(6) IS FOR THE HANDLE "HIQ+", ERGO S, UNIPOLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911611 ↗
• InjuryJan 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT AFTER A THERAPEUTIC VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED, IT WAS NOTICED THAT THE SCREW OF THE HINGE AXIS OF THE UNIPOLAR HANDLE WAS MISSING. THE PATIENT WAS THEN RE-OPENED ON THE SAME DAY AND THE COMPONENT RETRIEVED FROM THE PATIENT¿S THORACIC CAVITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8243591 ↗