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

Model Number	SIGMRET
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: egia45axt egia45 artic extra thicksulu (lot#: n2g0302y); sigadaptxl, sig power sigadaptxl linear xl adapter (serial#: (b)(6)); 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.
Event or Problem Description
According to the reporter, during a rectosigmoidectomy procedure, when closing the fabric, the excessive stop icon appeared on the display, the user awaited about 20 seconds for the fabric to settle and the signal came out and it started stapling, until halfway through the message appeared again, we waited a little longer and the it didn't even come off the display, so when it resumed charging, the stapler no longer responded.More.User tried to carry out all the maneuvers taught in the certification for opening the load, however, nothing worked, the surgeon decided to keep the load attached and continue with the surgery.It was no longer necessary to change, as the rod broken when the surgeon tried to open the load locked in the tissue, the user was able to removed the rod from the cavity.It was replaced with another rod for a new shot.
Event or Problem Description
According to the reporter, during a rectosigmoidectomy procedure, when closing the fabric, the excessive stop icon appeared on the display, the user awaited about 20 seconds for the fabric to settle and the signal came out and it started stapling, until halfway through the message appeared again, we waited a little longer and the it didn't even come off the display, so when it resumed charging, the stapler no longer responded.More.User tried to carry out all the maneuvers taught in the certification for opening the load, however, nothing worked, the surgeon decided to keep the load attached and continue with the surgery.It was no longer necessary to change, as the rod broken when the surgeon tried to open the load locked in the tissue, the user was able to removed the rod from the cavity.It was replaced with another rod for a new shot.It was also noted that retraction tool disengaged.
Additional Manufacturer Narrative
Correction: b5, h3, h6 additional information: 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.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the manual retract tool was noted to be broken into component parts.The coiled pin was noted to be disconnected from the two manual retract levers and was wrapped around the manual retract shaft.It was reported that the retraction tool was disengaged.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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 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: 19638700
• Report Number: 1219930-2024-02963
• Device Sequence Number: 7137787
• Product Code: GDW
• UDI-Device Identifier: 10884521543881
• UDI-Public: 10884521543881
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2024

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: C8G7401X
• 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: 06/01/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 09/26/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/26/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 NOTE ON H11
• Patient Age: 53 YR
• Patient Sex: Female