MAUDE Adverse Event Report: GYRUS ACMI INC. POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION

Model Number	PS-0544CJDA
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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 small bleeders, he would not always go to seal tone, but mostly would go to seal tone and apply multiple coagulation applications until bleeding stopped.Patients two and three were observed to have oozing/bleeding at the staple line (closed with ethicon staples-not powerseal).For these two patients, surgical drains were placed prior to closing incision.The tm also observed the user sometimes overloading the jaw.The tm was fairly certain there were no generator codes in any of the procedures as the error codes would have needed to be cancelled out manually.There was no observed malfunction of the device during any of the cases.Multiple attempts to obtain additional details (from the operating physician) regarding the patients and reported events have been made.At this time, no additional information has been provided.The charge nurse of the surgical center did state: ¿at this point there have been no incident reports filed internally regarding these events, so further details are available to me.¿ (b)(6) reports the patient returning to the er post procedure/discharge and requiring a blood transfusion.(this report) (b)(6) reports the second patient returning to er post procedure/discharge.During the procedure a drain was placed, and oozing observed from the staple line intra-procedurally.(b)(6) reports the third patient returning to er post procedure/discharge.During the procedure a drain was placed, and oozing observed from the staple line intra-procedurally.
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h4, h6, and h10.The device history records (dhrs) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 26 units were produced under this lot number with no associated reported deviations relating to the reported failure.Along with a dhr review, the other remaining devices from the boxes that were in stock were used by another doctor who found no issues.In the event description, it states: "from the supply coordinator that dr.Miles¿ partner dr.Schmitt did use the remaining 3 boxes (15 each) of powerseals in stock and had no issues." on page 7 of the device instructions for use (ifu) shipped with device, it mentions coagulating until the seal cycle complete tone sounds: "when the activation button is depressed, the generator emits a continuous tone to signal delivery of rf energy to the tissue or vessel between the device jaws.When the activation cycle is complete, a two-pulse seal cycle complete tone sounds and rf energy output ceases" the definitive cause of the reported event could not be established as none of the 3 devices were returned to olympus for evaluation, the initial complaint could not be confirmed, and a device evaluation could not be performed.Additional considerations: the event description mentioned: the territory manager ¿verifies that the patients were checked by both dr.Miles and the pa assisting with the case for any signs of bleeding before closing the patients.Both confirmed absence of bleeding." the event description also notes some comments and observations from during the procedure: "as for the question of hearing the seal tone, dr miles completed each energy application until seal tone stopped the energy to the device.When using energy to coag small bleeders, he would not always go to seal tone.".

• Brand Name: POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• Common Device Name: POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• Manufacturer (Section D): GYRUS ACMI INC.; 960 0 louisiana ave north; brooklyn park MN 55445
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 12917426
• Report Number: 3011050570-2021-00128
• Device Sequence Number: 5271137
• Product Code: GEI
• UDI-Device Identifier: 00821925044579
• UDI-Public: 00821925044579
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: PS-0544CJDA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ETHICON STAPLES.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown