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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 TA6035L
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/10/2021
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 sigmoidectomy, when sigmoid colon of anal side was resected, the device did not fire.It was squeezed, but there was no staples had been fired and second squeezing have not been able to be performed.A new device was used to complete the case.There was no patient injury.
 
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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 Key11435765
Report Number2647580-2021-00832
Device Sequence Number11602912
Product Code GDW
UDI-Device Identifier10884521043206
UDI-Public10884521043206
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/08/2021
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 Date11/30/2024
Device Model NumberTA6035L
Device Catalogue NumberTA6035L
Device Lot NumberP9M1372MY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2021
Initial Report FDA Received Date03/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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