MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB213, VOYANT MARYLAND SINGLE 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB213
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic sigmoidectomy.Event description: little to no energy was being delivered when the surgeon attempted to seal the vessel.The device made the audible noises to indicate that the device was working.The surgeon was grasping small intestine tissue when the event happened.No error messages or alarms were displayed on the generator.The user was able to note that low/no energy was being delivered when attempting to dissect the tissue.No tissue effect was observed.Thermal effects were not visible at the seal site.It is unknown if the surgeon activated the blade after hearing the end tone.Bleeding was not observed as a result of the incident.The device was used for about 3-4 activations before the experience was observed.This occurred during the first 10-15 minutes at the beginning of the procedure.The surgeon opened up a new handpiece to complete the case.No patient injury occurred.Product is available for return.Type of intervention: the surgeon opened up a new handpiece to complete the case.Patient status: no patient injury occurred.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of low energy output could not be replicated or confirmed as the event unit passed all relevant testing and functioned as intended.There were no visible non-conformances observed.Applied medical was 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 or Problem Description
Procedure performed: laparoscopic sigmoidectomy event description: little to no energy was being delivered when the surgeon attempted to seal the vessel.The device made the audible noises to indicate that the device was working.The surgeon was grasping small intestine tissue when the event happened.No error messages or alarms were displayed on the generator.The user was able to note that low/no energy was being delivered when attempting to dissect the tissue.No tissue effect was observed.Thermal effects were not visible at the seal site.It is unknown if the surgeon activated the blade after hearing the end tone.Bleeding was not observed as a result of the incident.The device was used for about 3-4 activations before the experience was observed.This occurred during the first 10-15 minutes at the beginning of the procedure.The surgeon opened up a new handpiece to complete the case.No patient injury occurred.Product is available for return.Type of intervention: the surgeon opened up a new handpiece to complete the case.Patient status: no patient injury occurred.

• Brand Name: EB213, VOYANT MARYLAND SINGLE 44CM, 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 16903163
• Report Number: 2027111-2023-00445
• Device Sequence Number: 17507434
• Product Code: GEI
• UDI-Device Identifier: 00607915140809
• UDI-Public: (01)00607915140809(17)251206(30)01(10)1473553
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K222284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 12/06/2025
• Device Model Number: EB213
• Device Catalogue Number: 101474691
• Device Lot Number: 1473553
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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: ALEXIS; APPLIED TROCARS; DISSECTORS; ETHICON; GRASPERS
• Patient Sex: Unknown