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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ILA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO ILA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 3971
Medical Device Problem Code Failure to Cut (2587)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during an open procedure, the device did not cut the tissue.The surgeon stated that when they fired the staple the knife did not cut but staples did a complete staple line.They stated that the blade ¿bowed¿ out from the shaft from there usable stapler.They stated this happened with two different loads.They manually cut between the staples and over sowed the staple line to complete the case.
 
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Brand Name
ILA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key7833067
Report Number2647580-2018-04321
Device Sequence Number19329393
Product Code GDW
UDI-Device Identifier10884521063167
UDI-Public10884521063167
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K885222
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2020
Device Model Number3971
Device Catalogue Number3971
Device Lot NumberP5H0657X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date08/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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