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 Problems Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 10/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter; during use a low anterior resection procedure for anastomosis, when the instrument was fired, the surgeon could not get the instrument out of the patient.The doctor assumes that the knife had not cut.There was an extension of surgery time by 1 hour, and tissue loss as the surgeon had to resect the first anastomosis, and create a new one.There was no additional blood loss, no change of procedure, and nothing fell into the patient cavity.No reinforcement material was in use at the time of the issue.The patient is reported to be okay without any report issue resulting from the extended surgical time.No further details regarding patient, product or procedure were provided by the reporter.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one eea 28mm single-use stapler.The visual inspection of the staple guide noted the instrument was fully applied.A microscopic examination of the device displayed nicks on the knife blade.Inspection of the anvil cutting ring showed shallow traces of knife impression and the ring was received partially severed.Functionally, the device was applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely, despite the noted knife blade damage.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.The information booklet cautions the user to make certain the section of the tissue to be stapled is free from any metal clips or similar structures; otherwise, the knife blade may not cut or the staple line may not properly form.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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6153477
• MDR Text Key: 61695187
• Report Number: 2647580-2016-01051
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P6B0337KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR