MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB212, VOYANT MARYLAND SINGLE 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB212

Device Problem Self-Activation or Keying (1557)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic ovarian cystectomy event description: (b)(6) 2023.Complaint product family: energy, product name: voyant maryland single-step, model number: eb212, lot number: unknown.The feedback was submitted as case observations by the surgeon, collected by the field rep on (b)(6) 2023.Email was received on (b)(6) 2023 that the feedback was determined as complaint.The event occurred during laparoscopic ovarian cystectomy procedure.First case trialing voyant eb212 - usual device is [competitor device].The surgeon commented that she felt the grasp zone was not as firm as [competitor device], leading to accidental activations when using as a grasper.Discussed grasp zone being different and to notice tactile feedback when activation button is compressed.The surgeon and her assistant both commented that voyant appeared to have more tissue build up on jaws than they were used to seeing needed cleaning at regular intervals.3 x cleans for this case of approximately 60 activations.Surgeon discussed oozing and bleeding as an issue in this case and she used multiple hemostatic agents.Explored this and the surgeon stated because she was not used to faster seal, she did not yet trust the seal cycle was complete with voyant due to bleeding around margins of cyst.The surgeon acknowledged this could be patient factors rather than device performance and agreed to continue evaluating voyant in open procedures as bleeding is easier to address in these cases and grasping zone is less of a factor.There is no clinical impact to the patient as a result of the event.It is unknown how the surgeon resolved the situation and what other instruments were used when the event occurred.There was no patient injury or illness associated with the complaint event.The patient is recovering well.Type of intervention: ni.Patient status: patient is recovering well.

Manufacturer Narrative

The event unit is not returning to applied medical for evaluation.A follow-up will be submitted upon completion of investigation.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, is it difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical was reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

Event Description

Procedure performed: laparoscopic ovarian cystectomy.Event description: on 28-nov-2023: complaint product family: energy, product name: voyant maryland single-step, model number: eb212, lot number: unknown.The feedback was submitted as case observations by the surgeon, collected by the field rep on 13-nov-2023.Email was received on 28-nov-2023 that the feedback was determined as complaint.The event occurred during laparoscopic ovarian cystectomy procedure.First case trialing voyant eb212 - usual device is [competitor device].The surgeon commented that she felt the grasp zone was not as firm as [competitor device], leading to accidental activations when using as a grasper.Discussed grasp zone being different and to notice tactile feedback when activation button is compressed.The surgeon and her assistant both commented that voyant appeared to have more tissue build up on jaws than they were used to seeing needed cleaning at regular intervals.3 x cleans for this case of approximately 60 activations.Surgeon discussed oozing and bleeding as an issue in this case and she used multiple hemostatic agents.Explored this and the surgeon stated because she was not used to faster seal, she did not yet trust the seal cycle was complete with voyant due to bleeding around margins of cyst.The surgeon acknowledged this could be patient factors rather than device performance and agreed to continue evaluating voyant in open procedures as bleeding is easier to address in these cases and grasping zone is less of a factor.There is no clinical impact to the patient as a result of the event.It is unknown how the surgeon resolved the situation and what other instruments were used when the event occurred.There was no patient injury or illness associated with the complaint event.The patient is recovering well.Patient status: patient is recovering well.

• Brand Name: EB212, VOYANT MARYLAND SINGLE 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: 18263673
• MDR Text Key: 330018955
• Report Number: 2027111-2023-00806
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K222284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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