MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit will not be returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: prostatectomy.Event description: during a prostatectomy, to achieve hemostasis dissection between the prostate and the plexus of santorini, the surgeon used the voyant.This one coagulated but did not loosen the jaws anymore.Current condition of the patient: the prostate was injured, torn on the anterior surface.Actions taken in the health care facility to manage the patient: immediately changed the instrument and check hemostasis and surrounding organs.Additional information received from applied medical representative via email 2jan23: indication for the surgery was prostatectomy for adenocarcinoma it was a full prostatectomy + lymph nodes.The manifestation of the injury lead to extended operating time, no additional diagnostics or medical/medicinal treatment, no admission to icu or extended hospitalization.Difficult to explain additional surgical treatment, but the anastomosis for the ureter was proceed differently and may occur leaks.Nothing notify for the moment about updated patient status.The device was removed by cutting around the jaw with a scalpel.There was tissue bleeding as a result from device removal.The bleeding was corrected with a monopolar and bipolar.Type of intervention: immediately changed the instrument and check hemostasis and surrounding organs.Patient status: the prostate was injured, torn on the anterior surface.
Additional 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, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.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: prostatectomy event description: lors d'une prostatectomie, pour réaliser l'hémostase dissection entre la prostate et le plexus de santorini, le chirurgien a utilisé le voyant.Celui-ci a coagulé mais n'a plus desserré les mors.État actuel du patient : la prostate a été lésée, déchirée sur la surface antérieure.Actions entreprises dans l¿établissement de soins pour la prise en charge du patient : changement immédiat de l'instrument et vérification de l'hémostase et des organes autour.Translation: during a prostatectomy, to achieve hemostasis dissection between the prostate and the plexus of santorini, the surgeon used the voyant.This one coagulated but did not loosen the jaws anymore.Current condition of the patient: the prostate was injured, torn on the anterior surface.Actions taken in the health care facility to manage the patient: immediately changed the instrument and check hemostasis and surrounding organs.Additional information received from applied medical representative via email 2jan23: indication for the surgery was prostatectomy for adenocarcinoma it was a full prostatectomy + lymph nodes the manifestation of the injury lead to extended operating time, no additional diagnostics or medical/medicinal treatment, no admission to icu or extended hospitalization.Difficult to explain additional surgical treatment, but the anastomosis for the ureter was proceed differently and may occur leaks.Nothing notify for the moment about updated patient status.The device was removed by cutting around the jaw with a scalpel.There was tissue bleeding as a result from device removal.The bleeding was corrected with a monopolar and bipolar.Additional information received from applied medical representative via email 12jan23: there was no damage to the ureter, the ureter was cut properly for the anastomosis.The surgeon had to create a different type of anastomosis than he had originally planned, he has adapt with another tissue.This new anastomosis may create leaks, because usually he use the part that was blocked into the jaws.The surgeon had to use a different technique, he had to improvise with the surrounding tissues.Type of intervention: immediately changed the instrument and check hemostasis and surrounding organs.Patient status: the prostate was injured, torn on the anterior surface.

• Brand Name: EB240, VOYANT OPEN FUSION, 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: 16123629
• Report Number: 2027111-2023-00310
• Device Sequence Number: 6560625
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)240715(30)01(10)1455774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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 Expiration Date: 07/15/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474398
• Device Lot Number: 1455774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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: EA020 GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown