Olympus PS-0523CJDARecalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00821925044531), received between Apr 18, 2023 and Sep 29, 2026 — classified as 2 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (30 reports).

3 FDA recall records name this device's identifier, 3 still open.

4 other recalls cover devices cleared under the same FDA submission (K212643); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 18, 2026Open, Classified

   Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

   Z-3035-2026 · Root cause: Labeling Change Control · FDA record ↗

2. Mar 7, 2024Open, Classified

   Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

   Z-1699-2024 · Root cause: Process control · FDA record ↗

3. Aug 12, 2022Open, Classified

   An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

   Z-1813-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935130 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  The customer reported Energy Output Problem involving an Olympus Powerseal. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922435 ↗
• MalfunctionSep 23, 2026Failure to Deliver Energy

  The customer reported that the output pathway though had stopped, involving an Olympus Power Seal curved jaw sealer. The procedure type was therapeutic, the procedure name was unknown. The intended procedure was completed with an Olympus back-up device. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871333 ↗
• MalfunctionSep 16, 2026Failure to Deliver Energy; Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782428 ↗
• MalfunctionAug 12, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224475 ↗
• MalfunctionApr 28, 2026Failure to Seal

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER HAD NO STICKING IN THE EARLY STAGES OF THE SURGERY, BUT IT OCCURRED FROM THE MIDDLE OF THE SURGERY, AND SINCE EVEN WIPING WITH A WET GAUZE DID NOT IMPROVE THE STICKING. THE ISSUE WAS FOUND DURING A PULMONARY SEGMENTECTOMY, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018539 ↗
• MalfunctionApr 14, 2026Activation Problem

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER & DIVIDER HAD POOR ACTIVATION. THIS MALFUNCTION OCCURRED DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876846 ↗
• MalfunctionMar 19, 2026Activation Failure

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER & DIVIDER HAD A CUT FUNCTION OPERATING FAILURE DURING A THERAPEUTIC HEMICOLECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640645 ↗
• MalfunctionMar 16, 2026Fitting Problem; Connection Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERSEAL EXHIBITED THE RECOGNITION PIN WAS BENT, PREVENTING THE CONNECTOR FROM BEING FULLY INSERTED AND CAUSING IT TO FAIL TO BE RECOGNIZED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604822 ↗
• MalfunctionMar 13, 2026Material Twisted/Bent

  NO ADDITIONAL INFORMATION FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594498 ↗
• MalfunctionMar 13, 2026Failure to Seal

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594208 ↗
• MalfunctionMar 11, 2026Mechanical Jam

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER, THE OPENING OR CLOSING HANDLE FELT HEAVY. THE ISSUE WAS FOUND DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THERAPEUTIC PROCEDURE. THE ISSUE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573046 ↗
• MalfunctionFeb 4, 2026Misconnection; Energy Output Problem

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER THE ELECTROCAUTERY KNIFE FAILED TO RESPOND. THE ISSUE WAS FOUND DURING A LAPAROSCOPIC HYSTERECTOMY, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260877 ↗
• MalfunctionFeb 2, 2026Activation Problem

  IT WAS REPORTED THE POWERSEAL GENERATOR SHOWED E619 DATA TRANSFER ERROR, UNABLE TO ACTIVATE AFTER FIVE ATTEMPTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234588 ↗
• MalfunctionJan 23, 2026Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172757 ↗
• MalfunctionJan 16, 2026Energy Output Problem

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103617 ↗
• MalfunctionJan 16, 2026Retraction Problem

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101904 ↗
• MalfunctionJan 12, 2026Failure to Seal

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048063 ↗
• MalfunctionJan 9, 2026Energy Output Problem

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023248 ↗
• MalfunctionJan 9, 2026Energy Output Problem

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER AND DIVIDER HAD AN ERROR OCCURRED DURING A APPENDECTOMY, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021472 ↗
• MalfunctionJan 5, 2026Activation Problem

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969455 ↗
• MalfunctionJan 2, 2026Energy Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951223 ↗
• MalfunctionDec 30, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER BECAME UNUSABLE AFTER AN ERROR OCCURRED. THE ISSUE WAS FOUND DURING AN ARTIFICIAL ANUS CONSTRUCTION, THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931292 ↗
• MalfunctionDec 30, 2025Energy Output Problem; Energy Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928073 ↗
• MalfunctionDec 30, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE POWERSEAL HAD NO OUTPUT WHEN THE NEW SUBJECT DEVICE WAS OPENED AND PLUGGED INTO A DEVICE DURING PRE-INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212643. One submission often covers many models, so check the product and lot details in each record.

• Z-1701-2024 · Mar 7, 2024 · Open, Classified
  POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascul
• Z-1700-2024 · Mar 7, 2024 · Open, Classified
  POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascul
• Z-1814-2022 · Aug 12, 2022 · Open, Classified
  Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surg
• Z-1815-2022 · Aug 12, 2022 · Open, Classified
  Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surg