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

Model Number SIGPHANDLE

Device Problems Entrapment of Device (1212); Retraction Problem (1536)

Patient Problem Tissue Breakdown (2681)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: egia60avm egia 60 artic vasc med sulu (lot#: p3k1044); sigpshell, sig power sigpshell control shell (lot#: n3l1816y); sigadaptstnd, sig power sigadaptstnd linear adapter (serial#: (b)(6)) 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.

Event Description

According to the reporter, during a laparoscopic small bowel transection , the jaws of the device lock on tissue, the user tried extracting tool and it would not retract knife blade.The stuck device was cut off and re-stapled to resolve the issue.

Manufacturer Narrative

D10 concomitant product: sigpshell, sig power sigpshell control shell (lot#n3k2781y); sigpshell, sig power sigpshell control shell (lot#n3k2781y).Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The electronic d evice-use logs were also provided.Post market vigilance (pmv) led an evaluation of one signia powered handle.During the investigation a secondary condition of fatal error caused by software restrictions was detected.This condition has a potential for patient ha rm.Analysis of the handle log noted a fatal error caused by software restrictions on the queue.This failure will result in the handle becoming unresponsive.It was reported that the jaws of the device lock on tissue.The reported issue was confirmed.The most likely cause was traced to software coding.Internal process improvements have been initiated to mitigate this issue.It was also reported that the user tried extracting tool and it would not retract knife blade.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of screen burn-in not related to the reported condition.Visual inspection noted that there was a faded/burnt in section of the organic light-emitting diode (oled) screen.The root cause of the oled screen having a burnt in section on its display is due to the display showing the same image on the display for a prolonged period of time.The handle is programmed to turn off the display when not in use.However, when components are left connected to the handle by the user, the amount of time it takes the screen to shut off is extended.A cross functional team has reviewed the risk and rate of occurrence for this failure and has determined that no corrective actions are warranted at this time.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18651989
• MDR Text Key: 334737431
• Report Number: 1219930-2024-00579
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Date Device Manufactured: 11/10/2021
• 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 NOTE ON H10; SEE NOTE ON H10