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

Model Number	SIGPHANDLE
Medical Device Problem Codes	Misfire (2532); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic sleeve gastrectomy, during stapling of the stomach, while using the first 60mm reload, the firing stopped at 50% with a notification of excessive force on the handle.The surgeon paused for a few seconds and tried to resume the firing multiple times with no success.The reload was retracted and removed, and a second 60mm reload was used.The second reload also stopped with excessive force and could not advance.A third reload was attempted to be used; however, the same excessive force error occurred.The surgeon decided to use a new handle, shell, adapter and a fourth 60mm reload.Again, the reload stopped and did not advance.At that point, a manual handle was opened with a new reload, and the surgeon stapled medial to the previous firing, and with much difficulty, and several crunches of the handle; the reload was successfully deployed.No patient injury.
Additional Manufacturer Narrative
Concomitant medical product/s: sigtrsb60amt 60mm med thk reinforced rel lot #:n2l0113y sigtrsb60amt 60mm med thk reinforced rel lot #:n2l0113y sigtrsb60axt 60mm xtr thk reinforced rel lot #:n2j0033y sigtrsb60axt 60mm xtr thk reinforced rel lot #:n2g0594y sigadaptxl sig power sigadaptxl linear xl adapter serial #:unknown sigpshell sig power sigpshell control shell lot #:unknown egiauxl endogia ultra univ xl stapler lot #:unknown sigtrsb60axt 60mm xtr thk reinforced rel lot #:unknown sigtrsb60amt 60mm med thk reinforced rel lot #:n2l0113y.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
• Common Device Name: 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: 16283289
• Report Number: 1219930-2023-00422
• Device Sequence Number: 14641965
• Product Code: GDW
• UDI-Device Identifier: 10884521797437
• UDI-Public: 10884521797437
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: SIGPHANDLE
• Device Catalogue Number: SIGPHANDLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown