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

Model Number	IDRVULTRA2
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intraoperatively, the cutting assembly system dragged the tissue.The jaws locked on the tissue.The tissue was damaged, so the surgeon dissected the injured and subsequently cauterized to avoid bleeding.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.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.

• Brand Name: IDRIVE ULTRA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11377623
• Report Number: 1219930-2021-00756
• Device Sequence Number: 3712232
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IDRVULTRA2
• Device Catalogue Number: IDRVULTRA2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention