MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB010, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB010
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy.Event description: surgeon mentioned the device was activating its seal cycle without him pressing the activation button and an unrecognized sound was heard from the device jaws at the beginning of the surgery.Laparoscopic technician switched the voyant device key from one port to the other one, without resolving the mentioned event, she then turned off the generator and back on, but the surgeon mentioned it remained the same.A new voyant device eb010 1445305 and the surgery was successfully completed.Product available for return.Type of intervention: laparoscopic technician switched the voyant device key from one port to the other one, without resolving the mentioned event, she then turned off the generator and back on patient status: good.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy.Event description: surgeon mentioned the device was activating its seal cycle without him pressing the activation button and an unrecognized sound was heard from the device jaws at the beginning of the surgery.Laparoscopic technician switched the voyant device key from one port to the other one, without resolving the mentioned event, she then turned off the generator and back on, but the surgeon mentioned it remained the same.A new voyant device eb010 1445305 and the surgery was successfully completed.Product available for return.Type of intervention: laparoscopic technician switched the voyant device key from one port to the other one, without resolving the mentioned event, she then turned off the generator and back on patient status: good.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of unintended rf energy output.Upon closer inspection, an internal fuse switch was observed to be misaligned.Based on the condition of the returned unit and the description of the event, it is likely that the unintended rf output was caused by the misaligned fuse switch.

• Brand Name: EB010, VOYANT 5MM FUSION 37CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15506267
• Report Number: 2027111-2022-00748
• Device Sequence Number: 5255989
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)230906(30)01(10)1445305
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K193292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1445305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VOYANT ESG EA010 S/N: (B)(4).
• Patient Sex: Unknown