MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIAUNIVXL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
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, during laparoscopic colectomy, upon colon resection, there was problem unloading the device and shaft of the handle broke off.Another product was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the shaft of the instrument to be broken, the device was pre-fired, engaged in interlock, and the jaws were clamped.It was reported that the device broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.Staple pre-fire and/or inability to open the jaws after clamping may occur under the following conditions: first, the shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.Second, the shipping wedge has been removed or is no longer fully seated in the metal channel and the jaws have been manually clamped prior to loading.Third, the shipping wedge has been removed or is no longer fully seated in the metal channel and an attempt has been made to load a loading unit with the instrument firing rod extended.Please note that the yellow shipping wedge must be securely in place during instrument loading.The shipping wedge ensures that the sulu engages in the instrument to facilitate clamping and unclamping.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: do not attempt to remove the shipping wedge until the sulu is loaded into the instrument.The broken rotation collar may occur due to over flexure of the loading unit while attached to the instrument.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.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 11516760
• Report Number: 2647580-2021-00995
• Device Sequence Number: 11620560
• Product Code: GDW
• UDI-Device Identifier: 10884523003512
• UDI-Public: 10884523003512
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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 Expiration Date: 11/30/2024
• Device Model Number: EGIAUNIVXL
• Device Catalogue Number: EGIAUNIVXL
• Device Lot Number: P9M1288Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1