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

Model Number SIGADAPTSTND

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

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant products: sigphandle, sig power sigphandle handle (sn:(b)(6) sigpshell, sig power sigpshell control shell egia60amt, egia60amt egia 60 artic med thick sulu 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, during a laparoscopic rectal resection, after loading the reload to the powered handle, the first firing could be done until the end and was completed.However, the knife could not be retracted, the jaws of the reload could not be opened, and it was locked on the tissue.When the display was observed, a power handle error of red circle with a slash and yellow exclamation mar was shown even upon attempting a powered approach.Once the error display was as is, a manual adapter tool was used for manual approach.The reload was then opened physically, and the tissue was released.It was noted that there were no problems with the staple line, and the operation was completed successfully afterwards.After the surgery, the handle display was checked again, but the same error display did not change.There was no patient injury.

• 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: 19106547
• MDR Text Key: 340240398
• Report Number: 1219930-2024-01579
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543805
• UDI-Public: 10884521543805
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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?: No
• Date Manufacturer Received: 03/19/2024
• 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