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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER STAPLE, IMPLANTABLE

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER STAPLE, IMPLANTABLE Back to Search Results
Model Number EEA28
Device Problem Failure to Cut (2587)
Patient Problem Tissue Damage (2104)
Event Date 11/03/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter, the device stapled but didn't cut. The surgeon had to remove the device with a long clamp. The anastomosis was torn off, an ileostomy had to be done. A suture with wire had to me made to close the tear of the anastomosis. The surgery time was extended by more than 30min. Additional information has been requested but not yet received.

 
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Brand NameEEA 28MM SINGLE-USE STAPLER
Type of DeviceSTAPLE, IMPLANTABLE
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 Key6157872
MDR Text Key61879539
Report Number2647580-2016-01058
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
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 11/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2020
Device MODEL NumberEEA28
Device Catalogue NumberEEA28
Device LOT NumberP5M0220KX
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 Received11/14/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2015
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: 12/09/2016 Patient Sequence Number: 1
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