MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® FINE FUSION DEVICE; 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: thyroidectomy.Event date is unknown.Event description: complaint 1 of 7: (b)(4).Complaint 2 of 7:(b)(4).Complaint 3 of 7: (b)(4).Complaint 4 of 7: (b)(4).Complaint 5 of 7: (b)(4).Complaint 6 of 7: (b)(4).Complaint 7 of 7: (b)(4).In a case study in a hospital in portugal, the surgeon happened to mention that in the past year they've had 7 post op bleeding cases while using a voyant handpiece (to be confirmed which one, most likely fine fusion).Additional information received from company rep.Via pcf on 22aug24: the surgeons informed that last year had some post op bleeding and the patients went again to the or.Couldn't specify if the event was voyant related.Surgeon is going to see the files and inform asap if it were surgeries where voyant were used.No need a closing letter.Additional information from call with company rep.On 27aug24 (see attachment "2024-002142 - 2024-002148 call discussion summary 27aug24").7 post-operative bleeding events happened sometime last year (2023); the specific event dates are unknown.The complications are probably linked to the use of voyant handpieces: still yet to be confirmed with the surgeon.The patients are fine, and the post-operative bleeding complications were successfully treated.Given that these events happened relatively long ago, the faulty devices are unlikely to be recovered and won¿t be available for investigation.No ¿confirmation of receipt¿ is needed at this point and no closing letter has been requested.Type of intervention: patients went again to the or patient status: post-operative bleeding.
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.Applied medical has performed a historical trend analysis and review of production records and no relevant documents were identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: thyroidectomy.*event date is unknown* event description: complaint 1 of 7: (b)(4).Complaint 2 of 7: (b)(4).Complaint 3 of 7: (b)(4).Complaint 4 of 7: (b)(4).Complaint 5 of 7: (b)(4).Complaint 6 of 7: (b)(4).Complaint 7 of 7: (b)(4).In a case study in a hospital in portugal, the surgeon happened to mention that in the past year they've had 7 post op bleeding cases while using a voyant handpiece (to be confirmed which one, most likely fine fusion).Additional information received from company rep.Via pcf on 22aug24: the surgeons informed that last year had some post op bleeding and the patients went again to the operating room.Couldn't specify if the event was voyant related.Surgeon is going to see the files and inform asap if it were surgeries where voyant were used.No need a closing letter.Additional information from call with company rep.On 27aug24 (b)(4) 7 post-operative bleeding events happened sometime last year ((b)(6) 2023); the specific event dates are unknown.The complications are probably linked to the use of voyant handpieces: still yet to be confirmed with the surgeon.The patients are fine, and the post-operative bleeding complications were successfully treated.Given that these events happened relatively long ago, the faulty devices are unlikely to be recovered and won¿t be available for investigation.No ¿confirmation of receipt¿ is needed at this point and no closing letter has been requested.Type of intervention: patients went again to the or.Patient status: post-operative bleeding.

• Brand Name: VOYANT® FINE FUSION DEVICE
• 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: 20101390
• Report Number: 2027111-2024-00811
• Device Sequence Number: 7571049
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 12/06/2024

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: EB230
• Was Device Available for Evaluation?: No
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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