MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM); STAPLER, SURGICAL

Model Number EEA31

Device Problem Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No further details regarding patient, product or procedure were provided by the reporter.

Event Description

According to the reporter; during a colectomy procedure the stapler didn't fire completely.The donut shape was not formed completely and the incomplete parts of the staple line had to be over sewn with suture.Other than the suture used to treat the issue, no other reinforcement material was in use with the stapling device at the time.No device component fell into the patient, and there was no tissue damage, tissue loss or blood loss.The procedure was extended by approximately 30 minutes.The most recent report of the patient's status was stable.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one eea 31mm single-use stapler.The visual inspection of the staple guide noted the instrument was fully applied.A microscope examination of the device displayed nicks on the knife blade.Inspection of the anvil cutting ring showed deep traces of knife impression and the ring was received completely severed.Functionally, the device reloaded with a full complement of staples and applied over the appropriate test media producing acceptable results.The reported condition was confirmed, due to the nicks on the knife blade.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM)
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6085371
• MDR Text Key: 59359150
• Report Number: 2647580-2016-00936
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P6D0725KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR