MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB230, VOYANT FINE FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
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: hemorrhoidectomy.The device was used properly, and also the territory manager was present during the surgery.At the end of the surgery the patient was in well conditions.And no complications was reported until this event.This patient underwent surgery on (b)(6) for grade 3 hemorrhoids.Before surgery, he had mucosal- homorrhoidal that was friable to the touch and signs of recent bleeding throughout the mucosa.On postoperative day 7, he was admitted to the hospital due to abundant rectal bleeding and was observed for two days without requiring reoperation.All lab tests are fine.Currently the patient is fine, he left the hospital today (b)(6) 2022 and has not presented any more bleeding.Currently the patient is fine, he left the hospital today (b)(6) 2022 after 2 days of observations and has not presented any more bleeding.
Event or Problem Description
Procedure performed: hemorrhoidectomy.Event description: the device was used properly, and also the territory manager was present during the surgery.At the end of the surgery the patient was in well conditions.And no complications was reported until this event.This patient underwent surgery on may 11 for grade 3 hemorrhoids.Before surgery, he had mucosal- homorrhoidal that was friable to the touch and signs of recent bleeding throughout the mucosa.On postoperative day 7, he was admitted to the hospital due to abundant rectal bleeding and was observed for two days without requiring reoperation.All lab tests are fine.Currently the patient is fine, he left the hospital today (b)(6) 2022 and has not presented any more bleeding.Additional information received by applied medical rep on 7sep22: i confirm to you, that the information provided is correct, in this case the adverse event occurs in the postoperative period 7 days later.The doctor explains to me that complications in an hemorrhoidectomy are usually expected at this time.Patient status: currently the patient is fine, he left the hospital today (b)(6) 2022 after 2 days of observations and has not presented any more bleeding.
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 as 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 or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: EB230, VOYANT FINE 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: 14688845
• Report Number: 2027111-2022-00632
• Device Sequence Number: 6609156
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)250124(30)01(10)1442955
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K202818
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 01/24/2025
• Device Model Number: EB230
• Device Catalogue Number: 101475465
• Device Lot Number: 1442955
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown