MAUDE Adverse Event Report: GYRUS ACMI, INC. POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION

Model Number	PS-0537CJSA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Vesicovaginal Fistula (4512); Urinary Incontinence (4572)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a powerseal curved jaw sealer and divider was used in two total laparoscopic hysterectomy (tlh).According to the physician, a thermal damage to the bladder was observed in both patients.Additional information was received from the customer that both patients developed a vesicovaginal fistula with massive urine loss on the eighth postoperative day.There was no intraoperative injury to the bladder, as verified with methylene blue.In this respect, the only possibility is thermal damage as per the customer.Additional information was requested but not available at this time.There were no further reports of patient harm.There was no allegation of product malfunction.This report is 1 of 2 patients.
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
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.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.Olympus will continue to monitor field performance for this device.

• Brand Name: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION
• Common Device Name: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION
• 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: 24774540
• Report Number: 3011050570-2026-00330
• Device Sequence Number: 13271145
• Product Code: GEI
• UDI-Device Identifier: 00821925044975
• UDI-Public: 00821925044975
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K231327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PS-0537CJSA
• Device Lot Number: WR478772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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: Female