Olympus PS-0537CJDARecalls & reported problems

Summary

The FDA's MAUDE database contains 184 adverse event reports that list this exact device (DI 00821925044555), received between Jul 25, 2022 and Sep 30, 2026 — classified as 14 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (52 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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-1700-2024 · Root cause: Process control · Recall details · FDA record ↗

2. 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-1814-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 184 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Contamination /Decontamination Problem

  The customer reported that there was a black stain adhered to the handle section involving an Olympus Powerseal. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948840 ↗
• MalfunctionSep 28, 2026Break

  The customer reported tip breakage during a therapeutic tumorectomy procedure involving a PowerSeal. There was no delay and the procedure was complete with an Olympus back up device. There was no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913316 ↗
• MalfunctionSep 25, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902637 ↗
• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer reported that there were black stains at multiple locations on the main body, involving an Olympus Power Seal curved jaw sealer. There was no procedure involved. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883214 ↗
• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer reported that there were black stains at multiple locations on the main body, involving an Olympus Power Seal curved jaw sealer. There was no procedure involved. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883032 ↗
• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer reported that there were black stains at multiple locations on the main body, involving an Olympus Power Seal curved jaw sealer. There was no procedure involved. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882923 ↗
• MalfunctionSep 21, 2026Failure to Power Up

  The customer reported that the subject device did not power on the first attempt, and even after trying about three times, there was no change in function, involving an Olympus Zoom Microscope Body. The issue was found during a Left adrenalectomy Therapeutic procedure. 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 50845930 ↗
• MalfunctionSep 16, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796444 ↗
• MalfunctionSep 16, 2026Failure to Seal

  The customer reported that the subject device had poor grounding, involving an Olympus PowerSeal curved Jaw sealer. The issue was found during an unknown Therapeutic procedure. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793821 ↗
• MalfunctionSep 15, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779634 ↗
• MalfunctionSep 14, 2026Failure to Deliver Energy; Key or Button Unresponsive/not Working

  The customer reported that after turning off the power once and trying to use POWERSEAL again, an i0486 error occurred and it became unusable, involving an Olympus PowerSeal curved Jaw sealer. The issue was found during a left hemicolectomy Therapeutic procedure. 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 50755366 ↗
• MalfunctionSep 10, 2026Connection Problem; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724960 ↗
• MalfunctionSep 10, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719230 ↗
• MalfunctionAug 31, 2026Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519013 ↗
• MalfunctionAug 14, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254545 ↗
• MalfunctionAug 13, 2026Failure to Cycle

  No additional information received from customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243891 ↗
• MalfunctionAug 13, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239178 ↗
• MalfunctionJul 31, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098867 ↗
• MalfunctionJul 30, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083059 ↗
• MalfunctionJul 27, 2026Failure to Seal

  The customer reported seal not completed appeared and sealing stopped during a therapeutic thoracoscopic esophagectomy procedure involving an Olympus Powerseal. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019826 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THE POWERSEAL'S JAW BROKE DURING THE UBERECTOMY THERAPEUTIC PROCEDURE. THE PROCEDURE WAS DELAYED BY FOUR MINUTES DURING SEDATION WHEN THE DEVICE WAS OUTSIDE THE PATIENT. 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 25218021 ↗
• MalfunctionMay 6, 2026Failure to Seal

  IT WAS REPORTED THE POWERSEAL HAD INCOMPLETE SEAL CYCLE ERROR. THE ISSUE WAS FOUND DURING 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 25094514 ↗
• MalfunctionMay 5, 2026Activation Failure

  IT WAS REPORTED THAT THE POWERSEAL FAILED TO SEAL. THE ISSUE WAS FOUND DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087790 ↗
• MalfunctionMay 1, 2026Device Damaged Prior to Use

  IT WAS REPORTED THE POWERSEAL WOULD NOT POWER UP WHEN CONNECTED TO THE GENERATOR. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061983 ↗
• MalfunctionApr 27, 2026Retraction Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERSEAL BLADE WAS STUCK AND COULD NOT BE CLOSED. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010393 ↗

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-3035-2026 · Aug 18, 2026 · Open, Classified
  POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
• 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-1699-2024 · Mar 7, 2024 · Open, Classified
  POWERSEAL 5 mm, 23 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-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
• Z-1813-2022 · Aug 12, 2022 · Open, Classified
  Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surg