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

Model Number	030412
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
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 total gastrectomy, the device was able to fire but could only push a little and unable to complete the closure, resulting to an incomplete staple line distally.In addition there were poor staple formation.To resolve the issue the surgeon used suture and hand sew the tissue.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the loading unit was partially fired, and the anvil clamping mechanism was deformed.Functional testing required the interlock to be overridden and the loading unit was applied to test media.The loading unit interlock was tested and found to function properly.It was reported that the device initially fires but failed to complete the firing cycle, and the staples did not form as expected.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.Deformed anvil clamping mechanism may occur either by firing over tissue that is beyond the recommended thickness range, or by firing with an obstacle incorporated in the jaws.In either of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly, and tissue may not be fully transected.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: preoperative radiotherapy may result in changes to tissue.These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size.Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size.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: 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: 11222348
• Report Number: 2647580-2021-00312
• Device Sequence Number: 677343
• Product Code: GDW
• UDI-Device Identifier: 10884523002911
• UDI-Public: 10884523002911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/19/2021

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 Expiration Date: 09/30/2024
• Device Model Number: 030412
• Device Catalogue Number: 030412
• Device Lot Number: P9K0456MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/19/2021
• 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
• Patient Age: 71 YR
• Patient Weight: 70