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

Model Number EEA28

Device Problems Component Missing (2306); Mechanics Altered (2984)

Patient Problem No Code Available (3191)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a low anterior resection procedure, it was noted that there was no staples inside the device.Hand sewn the anastomosis to complete the procedure.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the staple guide noted the instrument was fully applied.Pressure marks were observed on the pushers and strike marks were observed on the anvil head pockets indicating that the staples had been fired.The anvil of the instrument was observed to be tilted and attached to the instrument.A microscope examination of the device displayed nicks on the knife blade.Functionally, a representative staple guide was assembled to the instrument and applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely, despite the noted knife blade damage and the staple line was properly formed.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Additionally, the investigation detected a secondary condition of damaged knife that has no relationship to the reported conditions.No further actions have been deemed necessary at this time.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: EEA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8672403
• MDR Text Key: 147147806
• Report Number: 2647580-2019-02855
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523005530
• UDI-Public: 10884523005530
• Combination Product (y/n): N
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P8C1406KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 90