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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 Codes Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Codes Tissue Damage (2104); No Code Available (3191)
Date of Event 08/11/2020
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 the transection of the tissue on a j-pouch surgery, after firing the surgeon noticed an incomplete staple line and poor staple formation.The surgeon oversew the staple line to resolve the issue.It was noticed that the stapler had not been loaded properly by the scrub technician.
 
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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 Key10469222
Report Number2647580-2020-02763
Device Sequence Number2404192
Product Code GDW
UDI-Device Identifier10884521063167
UDI-Public10884521063167
Combination Product (Y/N)N
Initial Reporter StateNY
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 Health Care Professional
Type of Report Initial
Report Date (Section B) 08/28/2020
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 Number3971
Device Catalogue Number3971
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/12/2020
Initial Report FDA Received Date08/28/2020
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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