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

Model Number PS-0537CJDA

Device Problem Failure to Deliver Energy (1211)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Event Description

It was reported, the subject device had an incomplete seal cycle error occur when the seal button was pressed.The issue was found during a therapeutic laparoscopy-assisted distal gastrectomy (ladg) procedure and was completed using a similar device.Pre-use inspection was performed.There was no patient harm was reported by the customer.

• 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: 18933576
• MDR Text Key: 338085898
• Report Number: 3011050570-2024-10039
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925044555
• UDI-Public: 00821925044555
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: FR319724
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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