MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB217

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Perforation (2001)

Event Date 05/30/2021

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: laparotomy.Event description: emergency surgery was performed using voyant handpieces leftover from tender evaluations, surgeon was familiar with the device.During the surgery, small intestine of the patient got stuck in the latching mechanism, causing superficial damage, which was sutured by surgeon.Additional information received by email from applied medical representative on 03june21: patient status is not well, but the patient condition is not caused or affected by this incident.Rather the current condition is related to the illness he/she was treated for.Small intestine was pierced, corners of the metal plate in the latching mechanism left two holes to the small intestine.These holes where closed by suturing, and dr.[name] estimated that actual harm was very minimal.Surgeon stated that the handpiece was not broken, and this was clearly an user error.However he notified that similar user error would not be possible with some other devices, with different design.Device is not available, since the staff did not think at the time it could be useful, since it was not broken.Compensation is not needed.Date of event: (b)(6) 2021 (sunday).Model and lot number: eb217, lot unknown.Intervention: these holes where closed by suturing, and dr.[name] estimated that actual harm was very minimal.Patient status: patient status is not well, but the patient condition is not caused or affected by this incident.Rather the current condition is related to the illness he/she was treated for.

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 damages or non-conformances that could have contributed to the reported event.Based on the description of the event, the reported event is not indicative of a device non-conformance and was caused by user error.The instructions for use (ifu) states "keep cord and materials free from the jaw and latch area of the device".Correction: section h6 has been updated to reflect the findings of the evaluation.The component code has been updated to 1030 (latch) and 3067 (handpiece).The device code has been updated to 1212 (entrapment of device).

Event Description

Procedure performed: laparotomy.Event description: emergency surgery was performed using voyant handpieces leftover from tender evaluations, surgeon was familiar with the device.During the surgery, small intestine of the patient got stuck in the latching mechanism, causing superficial damage, which was sutured by surgeon.Additional information received by email from applied medical representative on 03june21: patient status is not well, but the patient condition is not caused or affected by this incident.Rather the current condition is related to the illness he/she was treated for.Small intestine was pierced, corners of the metal plate in the latching mechanism left two holes to the small intestine.These holes where closed by suturing, and dr.[name] estimated that actual harm was very minimal.Surgeon stated that the handpiece was not broken, and this was clearly an user error.However he notified that similar user error would not be possible with some other devices, with different design.Device is not available, since the staff did not think at the time it could be useful, since it was not broken.Compensation is not needed.Date of event: (b)(6) 2021 (sunday).Model and lot number: eb217, lot unknown.Additional information provided by territory manager via email 21july21: they are referring to the handle; when closing the jaws a piece of bowel was in between of the handle and corners of the latching mechanism pierced the bowel.Intervention: these holes where closed by suturing, and dr.[name] estimated that actual harm was very minimal.Patient status: patient status is not well, but the patient condition is not caused or affected by this incident.Rather the current condition is related to the illness he/she was treated for.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 6/BX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12042915
• MDR Text Key: 266071230
• Report Number: 2027111-2021-00538
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K200598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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
• Device Operator: Health Professional
• Device Model Number: EB217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERATOR