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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 STAPLER, SURGICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEA28
Device Problems Difficult to Remove (1528); Failure to Cut (2587)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 10/26/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

According to the reporter, during a colectomy, the device could staple but couldn't cut. The customer had to pull out on the device. The physician had to switch to a laparotomy to make another anastomosis properly. The procedure was finished with an ileostomy. The surgery time was extended by more than 30 minutes. The tissue was damaged.

 
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Brand NameEEA 28MM 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 Key6159293
MDR Text Key61921013
Report Number2647580-2016-01062
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK111825
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
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 Date01/31/2021
Device MODEL NumberEEA28
Device Catalogue NumberEEA28
Device LOT NumberP6A0496KX
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 Manufactured01/01/2016
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: 12/09/2016 Patient Sequence Number: 1
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