Olympus PS-0544CJDARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00821925044579), received between Dec 2, 2021 and Sep 22, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (3 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. How this data works · Data updated Oct 13, 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-1701-2024 · Root cause: Process control · 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-1815-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionSep 22, 2026Failure to Seal

  It was reported that during a therapeutic unknown procedure, the Powerseal curved jaw sealer and divider, would close and activate but would not seal. The customer stated attempts were made to change devices and cutting different tissue, but the issue did not resolve. A backup device was used to complete the procedure. No reports of patient injury or adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859004 ↗
• MalfunctionApr 27, 2026Failure to Seal

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER AND DIVIDER HAD A SEAL ERROR. THE ISSUE WAS FOUND DURING A THERAPEUTIC ROBOTIC MYOMECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008653 ↗
• MalfunctionApr 27, 2026Failure to Seal

  IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER AND DIVIDER HAD A SEALING FAILURE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ROBOTIC MYOMECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003889 ↗
• MalfunctionJan 16, 2026Difficult to Open or Close

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE POWERSEAL JAW DID NOT OPEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100572 ↗
• MalfunctionMay 8, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT DURING A ROBOT ASSISTED (DA VINCI) PROSTATECTOMY THERAPEUTIC PROCEDURE, THE POWERSEAL 5MM WAS USABLE AT THE START OF THE PROCEDURE, BUT HALFWAY THROUGH THE PROCEDURE, THE GRIP SECTION WAS UNABLE CLOSED. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986929 ↗
• MalfunctionOct 10, 2024Gas/Air Leak; Gas/Air Leak

  DURING THE DEVICE EVALUATION, THE HIGH FLOW INSUFFLATION UNIT EXHIBITED MANIFOLD AIR LEAKAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423732 ↗
• MalfunctionSep 16, 2022Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  IT WAS REPORTED DURING A THERAPEUTIC GASTRIC BYPASS PROCEDURE, SURGEON ACTIVATED THE POWERSEAL DEVICE, IT ALARMED AND STOPPED WITHIN 2 SECONDS AND THE GENERATOR ESG-410 SHOWED AN ERROR "INCOMPLETE SEAL". THE SURGEON RE-GRASPED TISSUE AND TRIED AGAIN, DID 3 MORE TIMES REGRASPING EACH TIME WITH THE SAME ERROR. THE SETTINGS ON ESG-410 WERE CHECKED AND FOUND CORRECT. ACCORDING TO THE REPORTER, THERE WAS NO OBVIOUS CLINICAL CAUSE FOR THE ERROR. NO STAPLES NEAR THE SITE AND NO INSTRUMENTS NEARBY. NO EXCESS FLUID AT SITE. JAWS WERE COMPLETELY CLOSED, AND THE LATCH WAS ON. AUDIBLE 'CLICK' HEARD WHEN JAWS WERE CLOSED. THERE WAS TISSUE GRASPED BETWEEN THE JAWS, NOT A SMALL AMOUNT, BUT ALSO NOT A LARGE BUNDLE. SOME FAT AND A BLOOD VESSEL. THE SEAL CYCLE WAS NOT INTERRUPTED EARLY BY RELEASING THE HAND GRASP. THERE WAS NO EXCESS COAGULUM ON THE JAWS AS THIS OCCURRED WITH THE 1ST USE AT START OF THE CASE AND WITH FIRST ACTIVATION, AND CONTINUED WITH EACH RE-ACTIVATION UNTIL THE 4TH ACTIVATION. AFTER THE 4TH RECURRENCE WITH SAME ERROR, SURGEON REMOVED DEVICE FROM TROCAR, ASKED SCRUB NURSE TO WIPE THE JAWS IN CASE THEY WERE NOT CLEAN, AND THEN SURGEON TRIED AGAIN. THE SAME ERROR OCCURRED. THE SURG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442641 ↗
• InjuryDec 2, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTS FOLLOWING SLEEVE GASTRECTOMY PROCEDURES USING A POWERSEAL SEALER AND DIVIDER, THREE PATIENTS WERE SEEN IN THE EMERGENCY ROOM (ER) AFTER BEING DISCHARGED FROM THE OUTPATIENT SURGERY CENTER HEMODYNAMICALLY STABLE WITH NO EVIDENCE OF BLEEDING. SEQUENCE OF EVENTS AS FOLLOWS: ALL THREE CASES WERE OBSERVED BY AN OLYMPUS TERRITORY MANAGER (TM). THE TM VERIFIES THAT THE PATIENTS WERE CHECKED FOR SIGNS OF BLEEDING PRIOR TO CLOSE OF INCISION. ABSENCE OF BLEEDING WAS VISUALLY AND VERBALLY CONFIRMED BY BOTH THE OPERATING PHYSICIAN AND THE PHYSICIAN¿S ASSISTANT PRESENT. ABSENCE OF BLEEDING WAS VISUALLY CONFIRMED THE TM PRESENT. FOR THIS PATIENT, LATER THE SAME DAY AFTER BEING DISCHARGED FROM THE OUTPATIENT SURGERY CENTER HEMODYNAMICALLY STABLE WITH NO SIGNS OF BLEEDING (AND A SURGICAL DRAIN PRESENT), THE PATIENT WAS SEEN IN THE ER. DURING THE PROCEDURE, THE TM DID OBSERVE OOZING/BLEEDING FROM THE STAPLE LINE. THE REASON FOR THE ER VISIT WAS NOT PROVIDED. IT IS NOT KNOWN WHAT IF ANY INTERVENTION WAS PROVIDED. CURRENT CONDITION IS UNKNOWN. OBSERVATIONS MADE BY THE TM DURING THE CASES: THE OPERATING PHYSICIAN COMPLETED EACH ENERGY APPLICATION UNTIL SEAL TONE STOPPED THE ENERGY

  Patient problems: Insufficient Information

  MAUDE report 12917452 ↗
• InjuryDec 2, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTS FOLLOWING SLEEVE GASTRECTOMY PROCEDURES USING A POWERSEAL SEALER AND DIVIDER, THREE PATIENTS WERE SEEN IN THE EMERGENCY ROOM (ER) AFTER BEING DISCHARGED FROM THE OUTPATIENT SURGERY CENTER HEMODYNAMICALLY STABLE WITH NO EVIDENCE OF BLEEDING. SEQUENCE OF EVENTS AS FOLLOWS: ALL THREE CASES WERE OBSERVED BY AN OLYMPUS TERRITORY MANAGER (TM). THE TM VERIFIES THAT THE PATIENTS WERE CHECKED FOR SIGNS OF BLEEDING PRIOR TO CLOSE OF INCISION. ABSENCE OF BLEEDING WAS VISUALLY AND VERBALLY CONFIRMED BY BOTH THE OPERATING PHYSICIAN AND THE PHYSICIAN¿S ASSISTANT PRESENT. ABSENCE OF BLEEDING WAS VISUALLY CONFIRMED THE TM PRESENT. FOR THIS PATIENT, LATER THE SAME DAY AFTER BEING DISCHARGED FROM THE OUTPATIENT SURGERY CENTER HEMODYNAMICALLY STABLE WITH NO SIGNS OF BLEEDING, THE PATIENT WAS SEEN IN THE ER. THE REASON FOR THE ER VISIT WAS NOT PROVIDED, HOWEVER IT IS PRESUMED THIS PATIENT WAS SEEN FOR A BLEEDING EVENT BECAUSE THE PATIENT REQUIRED A BLOOD TRANSFUSION. CURRENT CONDITION IS UNKNOWN. OBSERVATIONS MADE BY THE TM DURING THE CASES: THE OPERATING PHYSICIAN COMPLETED EACH ENERGY APPLICATION UNTIL SEAL TONE STOPPED THE ENERGY TO THE DEVICE. WHEN USING ENERGY TO COAGULATE SM

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12917426 ↗
• InjuryDec 2, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTS FOLLOWING SLEEVE GASTRECTOMY PROCEDURES USING A POWERSEAL SEALER AND DIVIDER, THREE PATIENTS WERE SEEN IN THE EMERGENCY ROOM (ER) AFTER BEING DISCHARGED FROM THE OUTPATIENT SURGERY CENTER HEMODYNAMICALLY STABLE WITH NO EVIDENCE OF BLEEDING. SEQUENCE OF EVENTS AS FOLLOWS: ALL THREE CASES WERE OBSERVED BY AN OLYMPUS TERRITORY MANAGER (TM). THE TM VERIFIES THAT THE PATIENTS WERE CHECKED FOR SIGNS OF BLEEDING PRIOR TO CLOSE OF INCISION. ABSENCE OF BLEEDING WAS VISUALLY AND VERBALLY CONFIRMED BY BOTH THE OPERATING PHYSICIAN AND THE PHYSICIAN¿S ASSISTANT PRESENT. ABSENCE OF BLEEDING WAS VISUALLY CONFIRMED THE TM PRESENT. FOR THIS PATIENT, LATER THE SAME DAY AFTER BEING DISCHARGED FROM THE OUTPATIENT SURGERY CENTER HEMODYNAMICALLY STABLE WITH NO SIGNS OF BLEEDING (AND A SURGICAL DRAIN PRESENT), THE PATIENT WAS SEEN IN THE ER. DURING THE PROCEDURE, THE TM DID OBSERVE OOZING/BLEEDING FROM THE STAPLE LINE. THE REASON FOR THE ER VISIT WAS NOT PROVIDED. IT IS NOT KNOWN WHAT IF ANY INTERVENTION WAS PROVIDED. CURRENT CONDITION IS UNKNOWN. OBSERVATIONS MADE BY THE TM DURING THE CASES: THE OPERATING PHYSICIAN COMPLETED EACH ENERGY APPLICATION UNTIL SEAL TONE STOPPED THE ENERGY

  Patient problems: Insufficient Information

  MAUDE report 12917368 ↗

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-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-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-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-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