MAUDE Adverse Event Report: GYRUS ACMI, INC. DAC (DISPOSABLE ACTIVE CORD); ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number LG05655

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  No Answer Provided  

Event Description

Gyrus acmi, dac, usa elite and usa series, disposable active cord disposable, did not function when hooked up to generator.A subsequent "like" device was then opened and functioned without issue.Upon further inspection, it was noted that a black piece of the plastic jaws was internally hanging from the top of the jaws, blocking the copper connectors.

• Brand Name: DAC (DISPOSABLE ACTIVE CORD)
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC. ; southborough MA 01772
• MDR Report Key: 8436383
• MDR Text Key: 139416644
• Report Number: MW5085025
• Device Sequence Number: 0
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: LG05655
• Device Catalogue Number: LG05655
• Device Lot Number: MK803678
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR