MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EA020, VOYANT GENERATOR, 1/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EA020
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: lap appendectomy.Event description: information in initial email: we had a report from th3 when using the [competitor trocar] laparoscopic system with the voyant, it was causing the camera screen to flicker on and off, can you advise have ye encountered the voyant to interfere with surrounding equipment previously.Complaint form information: lap appendectomy being performed in emergency theatre when camera stack went blank while activating the 5mm fusion (eb210) device.Case sopped and camera and accessories set up again.Same reaction to next activation.When the camera system was rebooted the surgeon [name redacted] discovered the tip of the lap voyant instrument had touched the adjoining structure cecum and caused a patient burn.The repair was done laparoscopically with lap staplers.Emergency theatre set up.Most electro surgical equipment in use were in close proximity.Patient was required to have cecum repaired post injury with laparoscopic staplers.Device was removed from the procedure.Generator used: 1368360 serial number (b)(6).Information received by applied medical representative via email on 23may23: i have checked with the hospital biomed who raised this issue and he has advised that the voyant instrument that was used during this procedure was disposed of following the surgery.I do not have access to the lot number.I note that [name redacted] have said there is no issue regarding the camera stack.Information received by applied medical representative via email on 24may23: the voyant system functioned correctly, and the hospital probably need to investigate the theatre set up as indicated in the ifu where rf interference can occur with proximity of electro surgical units in proximity.Type of intervention: intensive surgery to repair cecum following injury.Patient status: recovering well now but required more intensive surgery to repair cecum following injury.
Additional Manufacturer Narrative
The event device has returned 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 unintended thermal damage could not be replicated or confirmed as the event unit passed all testing and met current specifications.Based on the description of the event, it is likely that the reported event was caused by the voyant device being activated in close proximity to the camera, causing it to shut off and obstruct visibility.The user manual states that, ¿interference produced by the operation of high-frequency surgical equipment, such as electrosurgical generators/devices, may adversely influence the operation of other electrical equipment.Ensure that the generator is place an adequate distance from other electronic equipment.¿ the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: lap appendectomy event description: information in initial email: we had a report from th3 when using the [competitor trocar] laparoscopic system with the voyant, it was causing the camera screen to flicker on and off, can you advise have ye encountered the voyant to interfere with surrounding equipment previously complaint form information: lap appendectomy being performed in emergency theatre when camera stack went blank while activating the 5mm fusion (eb210) device.Case sopped and camera and accessories set up again.Same reaction to next activation.When the camera system was rebooted the surgeon [name redacted] discovered the tip of the lap voyant instrument had touched the adjoining structure cecum and caused a patient burn.The repair was done laparoscopically with lap staplers.Emergency theatre set up.Most electro surgical equipment in use were in close proximity.Patient was required to have cecum repaired post injury with laparoscopic staplers.Device was removed from the procedure.Generator used: (b)(6) serial number (b)(6).Information received by applied medical representative via email on 23may23: i have checked with the hospital biomed who raised this issue and he has advised that the voyant instrument that was used during this procedure was disposed of following the surgery.I do not have access to the lot number i note that [name redacted] have said there is no issue regarding the camera stack.Information received by applied medical representative via email on 24may23: the voyant system functioned correctly, and the hospital probably need to investigate the theatre set up as indicated in the ifu where rf interference can occur with proximity of electro surgical units in proximity.Type of intervention: intensive surgery to repair cecum following injury patient status: recovering well now but required more intensive surgery to repair cecum following injury.

• Brand Name: EA020, VOYANT GENERATOR, 1/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: 17725837
• Report Number: 2027111-2023-00594
• Device Sequence Number: 15258800
• Product Code: GEI
• UDI-Device Identifier: 00607915137601
• UDI-Public: (01)00607915137601(11)190909(30)01(10)1368360
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K182244
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EA020
• Device Catalogue Number: 101470971
• Device Lot Number: 1368360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 03/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EB215; LAP INSTRUMENTS; LAPAROSCOPIC CAMERA; TROCARS
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown