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

Model Number PS-0537CJDA

Device Problems Activation Failure (3270); Failure to Seal (4070)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

E1 address: (b)(6).The subject device is expected to be returned; however, it has not yet been received for evaluation, the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported the "powerseal device was plugged into the universal port and immediately a data transfer request came up when it was plugged in.Ok was pushed but every time the activation button was pressed the message came back up and the device would not work".Device showed a "message on epf-1c kept saying incomplete seal cycle".The event occurred in preparation for use for a therapeutic lap-hysterectomy.The device was replaced and the intended procedure was completed using a similar device.The reported problem did not impact the outcome of the procedure.There was no patient impact.No harm was reported due to the event.

Event Description

It was reported the "powerseal device was plugged into the universal port and immediately a data transfer request came up when it was plugged in.Ok was pushed but every time the activation button was pressed the message came back up and the device would not work".Device showed a "message on epf-1c kept saying incomplete seal cycle".The event occurred in preparation for use for a therapeutic lap-hysterectomy.The device was replaced and the intended procedure was completed using a similar device.The reported problem did not impact the outcome of the procedure.There was no patient impact.No harm was reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer's allegation was not confirmed.The product was returned in normal condition with foreign material on device.The product analysis confirmed that the device worked as intended with no message displayed on generator.No other issues were identified.Based on the results of the investigation, a definitive root cause cannot be identified.The most probable cause of the complaint is either it was not confirmed that there was a problem with the device, or it was confirmed that there was no problem with the device.A device history review was completed, and no issues were identified.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 18809264
• MDR Text Key: 336808046
• Report Number: 3011050570-2024-10017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS-0537CJDA
• Device Lot Number: FR357666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female