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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 Bent (1059); Positioning Problem (3009)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/17/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
 
Event or Problem Description
According to the reporter, during a laparoscopic sleeve gastrectomy procedure, the device was difficult or unable to close.The device was used and could not be mated to the instrument due to the center rod prongs being bent.A new device was used to complete the procedure.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 Key7100378
Report Number2647580-2017-08576
Device Sequence Number11130081
Product Code GDW
UDI-Device Identifier10884523005578
UDI-Public10884523005578
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K062850
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/08/2017
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 Date05/31/2022
Device Model NumberEEAXL21
Device Catalogue NumberEEAXL21
Device Lot NumberP7E0087KX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/17/2017
Initial Report FDA Received Date12/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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