MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211Z", 2.3 X 3000 MM

Model Number WA94005A

Device Problem Defective Device (2588)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

It was reported when using the single use plasma coagulation probe for cauterization, the plasma reportedly left a deep mark in the tissue.The plasma was used with the coagulation unit and electrosurgical generator.The procedure was completed with the same device.There were no reports of patient harm.Related patient identifier: (b)(6).Related patient identifier: (b)(6).

• Brand Name: SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211Z", 2.3 X 3000 MM
• Type of Device: SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211Z", 2.3 X 3000 MM
• 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: 18681493
• MDR Text Key: 336226213
• Report Number: 3011050570-2024-00052
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K180200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA94005A
• Device Lot Number: U2107088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARGON PLASMA COAGULATION UNIT "APU-300"; ESG-300 ELECTROSURGICAL GENERATOR