Olympus A60800ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04042761009843), received between Dec 6, 2019 and May 7, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THE HIQ+ SHAFT INSULATION WAS DAMAGED AND NOT POSSIBLE TO USE. THE ISSUE WAS FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111981 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT THE SHAFT EXTERNAL INSULATION ON THE EQUIPMENT SHAFT WAS DAMAGED. THE ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075715 ↗
• MalfunctionJul 2, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE INSULATION TIP PEEL. THE ISSUE WAS OBSERVED DURING PRE-USE INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381919 ↗
• InjuryJan 9, 2025Material Puncture/Hole; Material Puncture/Hole

  MEDWATCH REPORT MW5160877 RECEIVED: "PATIENT WENT IN FOR SURGERY TO ASSESS WHY PERITONEAL DIALYSIS CATHETER WAS NOT WORKING. WHILE IN SURGERY THE SURGEON HAD TO DISSECT ABDOMINAL ADHESIONS AND WHEN DOING SO CAUSED A SEROSAL INJURY TO THE PATIENT'S BOWEL DUE TO AN ELECTROCAUTERY MALFUNCTION. PATIENT WAS UNABLE TO RECEIVE A NEW PERITONEAL DIALYSIS CATHETER AND HAS SINCE HAD TO RECEIVE A FISTULA FOR FUTURE HEMODIALYSIS." ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PROCEDURE WAS CONVERTED FROM A LAPAROSCOPIC TO OPEN SURGERY. THE PROVIDER USED SEVERAL 3-0 SILK SUTURES OVER THE AREA OF INJURY DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SEROSAL BOWEL INJURY CAUSED THE PATIENT TO HAVE TO SWITCH FROM PERITONEAL DIALYSIS TO HEMODIALYSIS, REQUIRING HOSPITAL STAYS FOR THE HEMODIALYSIS. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE CUSTOMER REPORTED THE SUBJECT DEVICE HAD A SMALL HOLE IN THE INSULATION OF THE DEVICE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21119138 ↗
• InjuryJan 9, 2025Material Puncture/Hole; Material Puncture/Hole

  MEDWATCH REPORT MW5160877 RECEIVED: "PATIENT WENT IN FOR SURGERY TO ASSESS WHY PERITONEAL DIALYSIS CATHETER WAS NOT WORKING. WHILE IN SURGERY THE SURGEON HAD TO DISSECT ABDOMINAL ADHESIONS AND WHEN DOING SO CAUSED A SEROSAL INJURY TO THE PATIENT'S BOWEL DUE TO AN ELECTROCAUTERY MALFUNCTION. PATIENT WAS UNABLE TO RECEIVE A NEW PERITONEAL DIALYSIS CATHETER AND HAS SINCE HAD TO RECEIVE A FISTULA FOR FUTURE HEMODIALYSIS." ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PROCEDURE WAS CONVERTED FROM A LAPAROSCOPIC TO OPEN SURGERY. THE PROVIDER USED SEVERAL 3-0 SILK SUTURES OVER THE AREA OF INJURY DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SEROSAL BOWEL INJURY CAUSED THE PATIENT TO HAVE TO SWITCH FROM PERITONEAL DIALYSIS TO HEMODIALYSIS, REQUIRING HOSPITAL STAYS FOR THE HEMODIALYSIS. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE CUSTOMER REPORTED THE SUBJECT DEVICE HAD A SMALL HOLE IN THE INSULATION OF THE DEVICE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21119110 ↗
• MalfunctionMay 23, 2023Sparking; Sparking

  THE PROCEDURE WAS A THERAPEUTIC LAPAROSCOPIC SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986978 ↗
• InjuryMay 5, 2023Material Deformation; Separation Problem; Material Deformation; Separation Problem

  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 16882111 ↗
• InjuryFeb 22, 2023Material Deformation; Material Deformation

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC COLECTOMY PROCEDURE THE PATIENT SUSTAINED A BURN INJURY IN THE INTESTINES DUE TO A DAMAGED INSULATION. THE BURN IS THOUGHT TO HAVE REACHED THE SEROSA, BUT THERE IS A POSSIBILITY THAT IT MAY HAVE REACHED THE MUSCLE LAYER. SUTURING WAS PERFORMED ON THE BURN SITE.

  Patient problems: Burn(s); Necrosis

  MAUDE report 16415703 ↗
• InjuryDec 16, 2019Break; Break

  IT WAS REPORTED THAT AFTER A LAPASCROPIC CHOLECYSTECTOMY PROCEDURE WAS PERFORMED AND COMPLETED (INITIAL SURGERY PERFORMED ON (B)(6) 2019), THE PATIENT RETURNED AND COMPLAINED OF PAIN AROUND A MONTH LATER. THE PATIENT HAD AN X-RAY AND A FOREIGN OBJECT WAS IDENTIFIED. FOLLOW UP SURGERY WAS PERFORMED ON THE PATIENT ON (B)(6) 2019. THE FOREIGN DEVICE PART WAS REMOVED THROUGH LAPASCROPIC PROCEDURE. THIS COMPLAINT IS AGAINST THE SHAFT DEVICE USED DURING THE INITIAL PROCEDURE AND THIS IS ONE OF THE DEVICES THAT THE CUSTOMER BELIEVES THAT WAS FOUND IN THE PATIENT. THE FACILITY REQUESTED MANUFACTURERS OF ALL DEVICES POTENTIALLY INVOLVED IN THE ORIGINAL PROCEDURE TO INSPECT THEIR DEVICES.

  Patient problems: Pain

  MAUDE report 9476384 ↗
• MalfunctionDec 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC LAPAROSCOPIC PROCEDURE ON THE LARGE INTESTINE, THE RED BUTTON COVER OF THE RELEASE BUTTON OF THE HIQ+ SHAFT CAME OFF THE DEVICE. SINCE THE BUTTON COVER COULD NOT BE LOCATED ANYWHERE, AN X-RAY WAS PERFORMED BUT NO FOREIGN OBJECTS WERE FOUND INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9422619 ↗