MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB215, VOYANT MARYLAND FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB215

Device Problem Self-Activation or Keying (1557)

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

Procedure performed: cholecystectomy.Event description: [user facility] hospital."'ready' message dose not pop up, but 'check for stuck button' message appeared." product is available for return.Additional informaion was received via phone on (b)(6) 2023 from the complaint reporter (entered by (b)(6)) "the correct event date is on (b)(6) 2023.It seems the wrong event date was entered into the cer report when i filled out it." intervention: there was no problem with the patient.Patient status: n/a (no patient involvement).

Manufacturer Narrative

The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated as the event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.

Event Description

Procedure performed: cholecystectomy.Event description: [user facility] "'ready' message dose not pop up, but 'check for stuck button' message appeared." product is available for return.Additional information was received via phone on 09nov2023 from the complaint reporter: "the correct event date is 22jun2023.It seems the wrong event date was entered into the cer report when i filled out it." additional information received via email on 10nov2023 from complaint evaluation engineer ii: the lot number pulled from the hand device logs is 1458787.Intervention: there was no problem with the patient.Patient status: n/a.(no patient involvement).

• Brand Name: EB215, VOYANT MARYLAND FUSION 37CM, 6/BX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18116677
• MDR Text Key: 328509829
• Report Number: 2027111-2023-00724
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K200598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB215
• Device Catalogue Number: 101474481
• Device Lot Number: 1458787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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
• Treatment: GENERATOR