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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ROTICULATOR; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO ROTICULATOR; STAPLE, IMPLANTABLE Back to Search Results
Model Number 017619
Medical Device Problem Codes Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Tissue Damage (2104); No Code Available (3191)
Date of Event 09/07/2020
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 ligation of the lower right pulmonary vein on an open pulmonary lobectomy, the staples did not deploy properly and remained open, and it led to a bleeding.The surgeon had to clamp and suture the vein.This resulted to tissue damage.
 
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Brand Name
ROTICULATOR
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key10572005
Report Number2647580-2020-03068
Device Sequence Number3545946
Product Code GDW
UDI-Device Identifier10884521047730
UDI-Public10884521047730
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K855047
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/23/2020
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 Expiration Date08/31/2024
Device Model Number017619
Device Catalogue Number017619
Device Lot NumberP9J0995Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2020
Initial Report FDA Received Date09/23/2020
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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