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

Model Number	IDRVULTRA2
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the handle worked very well until the reload was loaded on adapter.Before firing, when the green button was pressed, there was no any flashing of light and stapler was unable to fire the reload.After closing jaw of reload and before firing, when pushing the green button, there was not any light blinking on handle and stapler was not able to fire.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: b5, d4(serial#, lot#), d9, e1, g1 (mfr contact first name, last name, street 1, mfr city, region, country code, postal code, email, phone number), g3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit showed signs of interior/exterior contamination.Functionally, the quick connect was depressed numerous times and showed no hang-ups or abnormalities.The articulation, rotation, close/fire, open and push to fire buttons and knobs were twisted and depressed all showing full functionality.An idrive battery was loaded into the handle.The handle powered up properly, calibrated successfully, and displayed a steady green light above the handle symbol.An idrive adapter (0055) was loaded unto the handle and calibrated without issue and displayed a solid green light above the adapter icon.A representative reload was inserted onto the adapter and the reload detect led immediately started flashing as intended.The reload was closed and then opened to change the flashing green reload detect led to a solid green state.The adapter was rotated in increments of forty-five degrees and fully articulated left and right each time, and the device recognized the reload the entire time.The green button was pressed, but the device wasn't able to enter firing mode.It was reported that the device did not fire.The reported issue was confirmed.The most likely cause was traced to the environment.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
Event or Problem Description
According to the reporter, prior to use, handle works very well till the reload was load on adapter.Before firing, when the green button was press, there was no any flashing of light and stapler was unable to fire the reload.After closing jaw of reload and before firing, when pushing the green button, there was not any light blinking on handle and stapler was not able to fire.Replacement for handle was requested to resolve the issue.There was no patient involvement.

• Brand Name: IDRIVE ULTRA
• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 11805576
• Report Number: 1219930-2021-01867
• Device Sequence Number: 11692912
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: IDRVULTRA2
• Device Catalogue Number: IDRVULTRA2
• Device Lot Number: N8F0922LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2018
• 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
• Patient Sex: Unknown