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

Model Number SIGADAPTXL

Device Problems Device Displays Incorrect Message (2591); Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

According to the reporter, during a gastric bypass procedure, but before using the stapler to the patient, the adapter was not accepting 2 reloads and the reloads were stuck on the adapter.The jaws of the reloads would not open.The handle, adapter, and 2 reloads were replaced to resolve the issue.There was no patient injury.

Manufacturer Narrative

D10 concomitant product: unknown egia su, unknown endo gia sulu (lot# unknown); sigphandle, sig power sigphandle handle (serial# unknown); unknown egia su, unknown endo gia sulu (lot# unknown).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.

Manufacturer Narrative

Additional information: b5, g3 correction: h6 (rfr-fdd has been updated) 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 gastric bypass, prior using the stapler to the patient, during the use of the first reload with the first adapter, the jaws did not open, and it was difficult to detach the reload; it was stuck.A second reload was connected to the same adapter and an adapter yellow swim lane error appeared.Then, a second adapter was connected to the second reload, to find another adapter error indicating that the adapter was out of lives.A new handle, adapter and reload were used to resolve the issue.There was no patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.The electronic device-use logs were also provided.Functionally, the adapter was connected to the adapter black box.The data saved to the adapter was read and a clamp test error was indicated.The main screen indicated the strain gauge was still functional and the analog to digital (a/d) count was within the range that should be accepted by the tare function based on the programmed values stated in the adapter log.The adapter was connected to a representative pmv handle.The handle displayed a yellow adaptor swimlane.A representative loading unit could be attached, articulated, clamped, unclamped, recognized, and detached without difficulty.The adapter had 34 of 50 procedures remaining before it was set to end of life.It was reported that the jaws did not open and it was difficult to detach the reload.The reported issues could not be confirmed.The most likely cause could not be established from the information available.It was also reported that an adapter yellow swimlane error appeared.The reported issue was confirmed.The most lik ely cause could not be established from the information available.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
• 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: 18809383
• MDR Text Key: 337239217
• Report Number: 1219930-2024-00951
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543812
• UDI-Public: 10884521543812
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024

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
• Device Operator: Health Professional
• Device Model Number: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 05/10/2024
• Supplement Dates FDA Received: 03/19/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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