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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 030418
Medical Device Problem Codes Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/02/2020
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, during video-assisted thoracoscopic surgery right superior lobectomy, when on the right upper lobe of the lung, the staples burst out when the interlobar fissure and vein were removed.There was poor staple formation and the suture was not smooth.The staple line was incomplete proximal that was fixed by firing again with a new unsealed staple.The surgeon removed cracked parts and staples with a cavity mirror.There was no patient injury.
 
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Brand Name
ENDO GIA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key9970642
Report Number2647580-2020-01369
Device Sequence Number16868294
Product Code GDW
UDI-Device Identifier10884523002959
UDI-Public10884523002959
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/16/2020
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 Date08/02/2023
Device Model Number030418
Device Catalogue Number030418
Device Lot NumberP8H1194MX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/02/2020
Initial Report FDA Received Date04/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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