MAUDE Adverse Event Report: GYRUS ACMI, INC. POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS-0523CJDA
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was not confirmed.A root cause could not be identified.Based on the results of the investigation: product analysis shows that the device met specifications.Visual inspection shows the returned device had no mechanical damage.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25018539
• Report Number: 3011050570-2026-00474
• Device Sequence Number: 10332424
• Product Code: GEI
• UDI-Device Identifier: 00821925044531
• UDI-Public: 00821925044531
• Combination Product (Y/N): N
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS-0523CJDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown