MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number SIGPHANDLE

Device Problems Entrapment of Device (1212); Mechanics Altered (2984); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

According to the reporter, during a robotic laparoscopic lower interior resection, the handle did not stop rebooting.It was noted that the handle was able to fire but would not retract, stuck on tissue and the handle started to reboot by itself.Once rebooted, the user had to take the handle off the adapter and reapply it and then the operator was able to remove it from the tissue.

Manufacturer Narrative

D10 concomitant products: unk-sigadapt, unknown signia egia adapter, (serial #unknown) nknown egia su, unknown endo gia sulu, (lot #unknown).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted there was contamination on the 7-pin connector.The oled (organic light-emitting diode) screen was discolored.The log files also indicate that prior to the last firing in the field there were multiple unknown continuous resets.The logs showed signs of the handle heating up, but the temperatures that the handle experienced were within specifications.The rear housing of the device was removed and damage was noted to the 44-pin flex cable on the ground pins where it connects to the motor board.It was reported that the handle was able to fire but would not retract, stuck on tissue and the handle started to reboot by itself.The reported issues were confirmed.The most likely cause of the observed damage to the flex cable was traced to device design.Damage to the ground pins can result in a continuous reset due to an intermittent connection.Internal process improvements have been initiated to mitigate this issue.The evaluation detected an unreported condition: vented battery.Visual inspection of the opened handle found the battery was vented, wet with electrolytic fluid.The root cause of the observed vented battery was determined to be due to a component degradation.The cell venting is an integrated design feature of the cell that produces a discharge of the electrolyte fluid and renders the battery cell nonfunctional and non-chargeable when battery cell life has been exceeded.Device battery management enhancements have been implemented to extend battery life and enhance battery health monitoring.Another unreported condition was identified: damaged electrical component.Functionally, there was damage noted to an internal transistor, resulting in piezo failure.The product analysis noted evidence that the device was not used as intended.The issue of the damaged electrical components resulting in loss of piezo function may occur due to rough handling such as the handle being dropped.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the power handle is a precise instrument.Care should be taken to avoid dropping, improper cleaning, improper handling or sterilizing the device.These actions may shorten device life and/or lead to device failure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIGNIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18292369
• MDR Text Key: 330252577
• Report Number: 1219930-2023-05103
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGPHANDLE
• Device Catalogue Number: SIGPHANDLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10