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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

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEA31
Device Problem Misfire (2532)
Patient Problem No Code Available (3191)
Event Date 09/22/2016
Event Type  Injury  
Manufacturer Narrative

(b)(6). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available. (b)(4).

 
Event Description

According to the reporter, during a sigmoid colectomy. The surgical time was delayed by more than 30 minutes. Device fragment was not left in the patient. They used several staplers and after firing staples where missing on either the top or bottom half of anastomosis. The surgeon said everything else looked good and they had 2 full donuts however, staples were missing on half of the anastomosis. They had to go lower in the pelvis and reconnect and staple with another device and the same thing happened again. Another manufacturer's device was used to complete the anastomosis. The case was delayed due to multiple attempts. Would not be filling it out and told me to ask (b)(6) to fill it out. I am not 100% sure if i am explaining all of this correctly due to not being in the case. This is literally all the information or detail i know.

 
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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, CT 06473
2034925267
MDR Report Key6051891
MDR Text Key58206458
Report Number2647580-2016-00864
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 09/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEEA31
Device Catalogue NumberEEA31
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 Received09/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/24/2016 Patient Sequence Number: 1
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