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

Model Number SIGADAPTSTND

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant products: sigphandle, sig power sigphandle handle (sn:unknown) unknown egia su, unknown endo gia sulu (lot#unknown).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Post market vigilance (pmv) led an evaluation of one signia adapter.Evaluation of the adapter log showed that the adapter had a tare error however the main screen indicated that the strain gauge was still functional and in the appropriate range.It was reported that an excessive load error was detected.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of universal asynchronous receiver-transmitter (uart) communications error.The most likely cause could not be established from the information available.Another unreported condition was identified of tare error.The root cause of the observed condition was determined to be the result of a material issue.The specified conformal coating material does not adequately protect the strain gauge circuitry on the proximal electrical assembly circuit board from residual moisture.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.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.

Event Description

According to the reporter, pre-operatively, attempts were made to cycle the stapler.Each time the jaws of a reload were closed, the same two screens appeared.The first displayed a "3" on the real-time feedback dial, and the second showed an excessive load error message.Closing the jaws of any reload without anything present produced the same results.Several attempts were made at recalibrating, detaching and reattaching the adapter, as well as trying different reloads, but all resulted in the same feedback.The handle worked fine with other adapters.There was no patient involvement.

• 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: 18949439
• MDR Text Key: 338556852
• Report Number: 1219930-2024-01265
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543805
• UDI-Public: 10884521543805
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGADAPTSTND
• Device Catalogue Number: SIGADAPTSTND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• 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 H11.