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

Model Number PS-0537CJDA

Device Problems Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus employee reported on behalf of the customer that during therapeutic total laparoscopic hysterectomy procedure the physician began using the powerseal 5mm, 37cm, curved jaw sealer & divider, double-action and the device failed to supply energy onto the tissue and the seal cycle could not be completed.An ¿incomplete seal cycle¿ error message 765 showed up on the generator each time the physician tried using the energy button during tissue sampling.Reportedly, the procedure was delayed (unknown time) due to the device malfunction.Hence the physician decided to switch to an open, total abdominal hysterectomy (therapeutic) procedure.There was no report of patient injury.Reportedly the condition of the patient was not impacted by the failure.No treatment was required outside the scope of the procedure; however it was noted that open procedure could affect the recovery of the patient.An olympus representative visited the hospital and troubleshooted the device.It was confirmed that the device was not emitting energy onto the jaw.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer¿s reported issue was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, although the reported issue was confirmed, the root cause of the adverse event could not be determined.This supplemental report includes information added to d9 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• Type of Device: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-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: 18031371
• MDR Text Key: 326869337
• Report Number: 3011050570-2023-00164
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925044555
• UDI-Public: 00821925044555
• Combination Product (y/n): N
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: PS-0537CJDA
• Device Lot Number: CA260235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESG -400 (HF GENERATOR), MODEL AND SERIAL-UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female