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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE Back to Search Results
Model Number EEAXL21
Medical Device Problem Codes Difficult to Remove (1528); Noise, Audible (3273)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, while being applied on anastomosis during a laparoscopic gastric bypass, the device never made an audible click after the 2 turns counterclockwise.It was also reported that the device was difficult to remove from the cavity, however, the surgeon had to slowly pulled it out and the device was removed successfully.There was no patient injury.
 
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Brand Name
EEA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key9203191
Report Number2647580-2019-05239
Device Sequence Number3031809
Product Code GDW
UDI-Device Identifier10884523005578
UDI-Public10884523005578
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K062850
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2021
Device Model NumberEEAXL21
Device Catalogue NumberEEAXL21
Device Lot NumberP6E0447KX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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