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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 3957
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/09/2018
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, for the third firing of colectomy procedure, they connected the cartridge to instrument; however, a white part of the cartridge was unstable.They considered the cartridge had no problem and connected it to the instrument.At functional side to side anastomosis, the surgeon inserted anvil fork and the cartridge from small opening at intestinal canal, and then closed the instrument.He tried to fire the device, however he could not.The procedure was completed with another device.The status of the patient was reported as no problem.
 
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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 Key7452534
Report Number2647580-2018-02013
Device Sequence Number173204
Product Code GDW
UDI-Device Identifier10884521064607
UDI-Public10884521064607
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K885222
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/23/2018
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 Model Number3957
Device Catalogue Number3957
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/10/2018
Initial Report FDA Received Date04/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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