• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEA31
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Tissue Damage (2104); Skin Tears (2516); Blood Loss (2597)
Event Date 03/25/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6).

 
Event Description

According to the reporter, after stapling for a colorectal transcutaneous anastomosis, force had to be used to remove the device. The colorectal anastomosis was torn off and there was bleeding.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Per additional information received, according to the reporter, an infra-peroneal rectal colorectal resection had to be performed due to the incident with the device. The procedure was performed by laparoscopy (laparoscopic sigmoidectomy). After the sigmoidectomy with staple section of the rectal stump at the end of the device, the head of a circular anastomosis clip had been put into the upstream colic slice. The clip was inserted as usual: trans-anal after dilation of the rectal stump by phantom candles. After perforating the rectal stump by the tip of the forceps, the head of the forceps were connected as usual. After the clamp was actuated, it was not possible to remove the clamp and after having tried to remove it, the clamp head remained attached to the anastomosis. It was found that there was no circumferential total cross-section causing the head of the gripper to be blocked. This was forcefully removed by the trans-anal route, which tore the colorectal anastomosis with a line of splitting on the rectum. It was therefore necessary to convert to a pubic laparotomy in order to intersect the rectum below the level of the peritoneum, which also allows haemostasis of the rectal tear responsible for haemorrhage. Rectal intersection stapling was done with another stapling device. A new trans-suture anastomosis was performed with a different device. It was possible to press on the handle, so the staples were partially released. The device partially fastened the fabrics. The incident occurred after application on the tissues which resulted in unexpected tissue loss, causing the tissues to be torn as a result of the incident. There was also irreversible tissue damage on the part of the rectal wall that was torn. The additional bleeding was approximately 300 to 400cc. There was no need for a blood transfusion. The surgical time was extended by at least one hour. The incident also prolonged the hospital stay. The patient developed sequelae with a low colorectal anastomosis stenosis which required two pneumatic dilations and transit disorders with rectal syndrome with multiple saddles per day, as well as pain. The patient is now doing well.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEEA 31MM SINGLE-USE STAPLER
Type of DeviceSTAPLER, 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 06473
MDR Report Key6043335
MDR Text Key57935931
Report Number2647580-2016-00850
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK062850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 09/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device MODEL NumberEEA31
Device Catalogue NumberEEA31
Device LOT NumberP5C0271KX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/20/2016 Patient Sequence Number: 1
-
-