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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE Back to Search Results
Model Number TA6048L
Medical Device Problem Codes Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient codes - c64343 (sutured/colostomy).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 to dissect the rectum, some staples were open and not formed properly after firing.The surgeon sutured to correct the open tissue.The doctor finished the surgery with a colostomy.
 
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Brand Name
TA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key10745891
Report Number2647580-2020-03478
Device Sequence Number19816622
Product Code GDW
UDI-Device Identifier10884521043220
UDI-Public10884521043220
Combination Product (Y/N)N
Initial Reporter CountryCE
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/28/2020
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 Model NumberTA6048L
Device Catalogue NumberTA6048L
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/10/2020
Initial Report FDA Received Date10/28/2020
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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