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

Model Number	EB240
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: colostomy closure & secum small bowel resection event description: this was an open case that the rep was present for.There was a total of 22 activations.On the 18th activation, while on the ileocolic artery, with the device about "75-80%" full, insufficient hemostasis was experienced.The surgeon attempted to activate the device on the tissue and vessel again, but the problem persisted for 4 additional activations and the bleeding was still uncontrolled.While a new eb240 was being unpackaged to be swapped with the problematic eb240, the surgeon cut and tied the open lumen with sutures and the bleeding was controlled.No patient injury occurred.The device was cleaned 9 times throughout the case.No improvement was noted after cleaning the jaws, post insufficient hemostasis.The new eb240 was used only on "avascular planes".As the case continued, oozing was noticed from previous seal sites and the new eb240 was used to reseal those areas.The surgeon noted that this added "significant time" to the case.The case took approximately 6 hours.The patient was diagnosed with diverticulitis and had a recent sigmoidectomy.The surgeon had 1 accidental release earlier in the procedure but this did not lead to any issues.The surgeon noted that the device's activation button felt "sensitive".The activation button was activated accidentally 4 times, but this occurred when the eb240 was not touching any tissue and this did not lead to any patient harm.These dry fires led to 4 "check device" alarms.Type of intervention: cut & tied with sutures.Patient status: no patient injury.
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 could not be replicated.The event unit met current specifications and there were no visible non-conformances.Applied medical has 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: colostomy closure & secum small bowel resection.Event description: this was an open case that the rep was present for.There was a total of 22 activations.On the 18th activation, while on the ileocolic artery, with the device about "75-80%" full, insufficient hemostasis was experienced.The surgeon attempted to activate the device on the tissue and vessel again, but the problem persisted for 4 additional activations and the bleeding was still uncontrolled.While a new eb240 was being unpackaged to be swapped with the problematic eb240, the surgeon cut and tied the open lumen with sutures and the bleeding was controlled.No patient injury occurred.The device was cleaned 9 times throughout the case.No improvement was noted after cleaning the jaws, post insufficient hemostasis.The new eb240 was used only on "avascular planes".As the case continued, oozing was noticed from previous seal sites and the new eb240 was used to reseal those areas.The surgeon noted that this added "significant time" to the case.The case took approximately 6 hours.The patient was diagnosed with diverticulitis and had a recent sigmoidectomy.The surgeon had 1 accidental release earlier in the procedure but this did not lead to any issues.The surgeon noted that the device's activation button felt "sensitive".The activation button was activated accidentally 4 times, but this occurred when the eb240 was not touching any tissue and this did not lead to any patient harm.These dry fires led to 4 "check device" alarms.Type of intervention: cut & tied with sutures.Patient status: no patient injury.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• 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: 15784710
• Report Number: 2027111-2022-00817
• Device Sequence Number: 17341125
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)241004(30)01(10)1463008
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201212
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 10/04/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1463008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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
• Patient Sex: Unknown