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

Model Number SIGPHANDLE

Device Problems Entrapment of Device (1212); Retraction Problem (1536); Device Displays Incorrect Message (2591); Mechanics Altered (2984)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2022

Event Type  malfunction  

Event Description

According to the reporter, during total laparoscopic distal gastrectomy, when transecting jejunum, the i-beam did not retreat, then a power handle error appeared.At the same time, message appeared to press the ready-to-fire buttons for 10 seconds.The user opened the jaws after pressing the ready-to-fire buttons for 10 seconds and another system was used to continue the case.

Manufacturer Narrative

Concomitant medical products: sigpshell sig power sigpshell control shell lot # unknown ,unk-sigadapt unknown signia egia adapter unknown 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

Additional information: d9, g3, h3, h6 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

Additional information: b5, g3, h6 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 total laparoscopic distal gastrectomy, when transecting jejunum, the i-beam did not retreat, then a power handle error appeared.At the same time, message appeared 'to press the ready-to-fire buttons for 10 seconds'.The user opened the jaws after pressing the ready-to-fire buttons for 10 seconds and another handle and adapter were used to continue the case.

Manufacturer Narrative

Additional information: e1(first name, last name), e3, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A video was also provided.The electronic device-use logs were also provided.Visual inspection noted the returned video contained a view of the reload as well as the handle display during the procedure.The reload was clamped over the tissue.At the 11 second mark, the handle began firing.There were no holdups or hesitations noted during firing.At the 31 second mark, the knife blade reached the end of the reload and the laparoscope was removed from the patient to capture the handle display.The handle was displaying a fatal error screen followed by the instructions for resetting the handle.At the 1 minute mark, the surgeon began the green key reset process.The laparoscope was reinserted into the patient.At 1:48, the laparoscope was removed from the patient and captured the handle display.The handle displayed the remove reload screen and went into emergency retract mode.The laparoscope was reinserted once more and the knife blade was seen retracting.At 2:21, the knife blade retracted fully and the jaws opened.Functional testing noted there were no abnormalities that would have caused or contributed to the reported condition.The handle had 274 of 300 procedures remaining.A clamshell and adapter were connected to the returned device and calibrated successfully.The device was able to fire without issues on the a1 machine.A reload was attached to the device and was able to clamp and articulate without any issues.The power to battery was never interrupted, there were no unexpected resets.There were no empty files with the system data.All button presses resulted in motor movements.Analysis of the handle data showed fatal errors before and after a firing.Handle data shows that the handle did not retract from firing before it was reset and difficulty in retracting the reload due to fatal errors.It was reported that the jaws of the device remain closed on tissue, the device did not work as expected, and the screen displayed a power handle error.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 16127342
• MDR Text Key: 308582060
• Report Number: 1219930-2023-00159
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543782
• UDI-Public: 10884521543782
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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