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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA PREMIUM; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO TA PREMIUM; STAPLE, IMPLANTABLE Back to Search Results
Model Number 015458L
Medical Device Problem Codes Loss of or Failure to Bond (1068); Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 09/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during pneumonectomy, the device was partially fired and there was a poor staple formation.After the sur gical procedure during the bronchoscopy, physician found out that stapler line was partially open.The patient was under 24 hour observation and currently hospitalized at the intensive care department.
 
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Brand Name
TA PREMIUM
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key8033252
Report Number2647580-2018-05263
Device Sequence Number13808241
Product Code GDW
UDI-Device Identifier10884521047402
UDI-Public10884521047402
Combination Product (Y/N)N
PMA/510(K) Number
K855047
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/02/2018
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 Date11/30/2022
Device Model Number015458L
Device Catalogue Number015458L
Device Lot NumberP7L1104X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2018
Initial Report FDA Received Date11/02/2018
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 Hospitalization; Required Intervention;
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