MAUDE Adverse Event Report: COVIDIEN SURGICAL SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGMRET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: sigadaptshort, sig power sigadaptshort lin short adapt (serial#:(b)(6) egia45amt egia 45 artic med thick sulu (lot#: unknown).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 or Problem Description
According to the reporter, during a lecture on the use of the power manual retract tool, the tool was damaged, resulting in the cartridge and adapter becoming irreversibly stuck and unable to be detached.There was no patient involved.
Additional Manufacturer Narrative
Additional information: b5, g3 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 or Problem Description
According to the reporter, during a lecture on the use of the power manual retract tool, the tool became damaged, resulting in the cartridge and adapter becoming irreversibly stuck and unable to be detached, and the jaws were unable to open.It was noted that the handle used was a powered handle however, the manual adapter tool cannot be used while the power handle is connected and requires disconnection prior to use.As a result, it was determined that the power handle was not related to the event and was not involved.There was no patient was involvement.
Event or Problem Description
According to the reporter, during a lecture on the use of the power manual retract tool, the tool was damaged, resulting in the cartridge and adapter becoming irreversibly stuck and unable to be detached.The jaws were unable to open.There was no patient involved.
Additional Manufacturer Narrative
Additional information: b5, g3, h6, d10, d10 concomitant product: sigadaptshort, sig power sigadaptshort lin short adapt (serial#: (b)(6)) egia45amt egia 45 artic med thick sulu (lot#: unknown) sigphandle, sig power sigphandle handle (serial#: unknown) 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the manual retract tool was broken.It was reported that during a lecture on the use of the power manual retract tool, the tool became damaged, resulting in the cartridge and adapter becoming irreversibly stuck and unable to be detached, and the jaws were unable to open.It was noted that the handle used was a powered handle however, the manual adapter tool cannot be used while the power handle is connected and requires disconnection prior to use.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if excessive torque is applied to the manual retract tool.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
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23667601
• Report Number: 1219930-2025-05492
• Device Sequence Number: 10298639
• Product Code: GDW
• UDI-Device Identifier: 10884521543881
• UDI-Public: (01)10884521543881(11)170606(10)C7E7402X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2026

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: SIGMRET
• Device Catalogue Number: SIGMRET
• Device Lot Number: C7E7402X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 12/04/2025; 01/23/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/02/2025; 12/18/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; SEE NOTE ON H11.
• Patient Sex: Unknown