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

Model Number GIA8038S

Device Problems Component Missing (2306); Component or Accessory Incompatibility (2897); Mechanics Altered (2984)

Patient Problem No Code Available (3191)

Event Date 10/16/2019

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 an open bowel resection, on side to side anastomosis, connecting two pieces of bowel after being transected, when they attempted to create a side-to-side anastomosis the stapler would not connect because it was not loaded properly.The doctor said that he was able to fix the issue and load the stapler correctly.When the surgeon fired the stapler, no staples deployed and the bowel was cut and no staples were to be found inside the cartridge.To fix the issue, the doctor transected the bowel that was cut but not stapled, approximately 80-100mm of bowel with a new handle and reload.They then created a side-to-side anastomosis and finished the case.The surgical time was extended by approximately thirty minutes.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No instrument was received.The loading unit was received fully applied with the interlock was engaged with no knife blade damage.Cracks were noted on the surface of the loading unit.Additionally, two properly formed staples were noted on the loading unit.The loading unit was reset and loaded into a test unit for functional testing.The test instrument and loading unit were applied to the appropriate test media with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may be due to use in tissue thicker than indicated.The ifu(instructions for use) states that if the tissue cannot comfortably compress to the minimum requirement, the tissue may be too thick or too thin for the selected staple size.The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition.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: GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9271753
• MDR Text Key: 164831894
• Report Number: 2647580-2019-05470
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523007268
• UDI-Public: 10884523007268
• Combination Product (y/n): N
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: GIA8038S
• Device Catalogue Number: GIA8038S
• Device Lot Number: P9E1344KY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention