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 Codes	Misconnection (1399); Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
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.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: b5, d9, h2, h6, h11 corrected fields: b6, b7, d7a, d8, d10, e3, e4, h5 based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The event can be detected by following the instructions for use which state: ¿the tissue grasped by the jaws is too small the operator is grasping thin or insufficient tissue.Open the jaws and ensure that an adequate amount of tissue is being grasped.If necessary, increase the thickness of the tissue being grasped, then press the coagulation pedal on the footswitch or the blue output button on this product.¿the tissue grasped by the jaws is too large the operator is grasping tissue that is too large.Open the jaws, reduce the amount of tissue being grasped, and then press the coagulation pedal on the footswitch or the blue output button on this product.¿rf radio frequency energy is being output to a metal object avoid grasping metal objects such as staplers or clips with the jaws.¿the jaws are dirty clean the surface and sharp parts of the jaws with a wet gauze.¿there is a large amount of fluid in the surgical field remove excess fluid from around the jaws.¿the output button was released before the seal was completed the coagulation pedal on the footswitch or the blue output button on this product was released before the seal was completed.¿the maximum seal processing time was reached the system requires more time to complete the seal.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: 24260877
• Report Number: 3011050570-2026-00133
• Device Sequence Number: 7975790
• Product Code: GEI
• UDI-Device Identifier: 00821925044531
• UDI-Public: 00821925044531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown