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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA PLATE, BASE, SHELLAC

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US SURGICAL PUERTO RICO EEA PLATE, BASE, SHELLAC Back to Search Results
Model Number TRIEEA28MT
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic procedure, on anastomosis of the rectum, it was difficult to remove the stapler form the cavity. The surgeon had to remove the instrument by inserting his finger rectally and assist digitally to remove the instrument. There was no patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic rectal resection with ileostomy procedure, on anastomosis of the rectum, it was difficult to remove the stapler from the cavity. The surgeon had to remove the instrument by inserting his finger rectally and assist digitally to remove the instrument. There was no patient injury.
 
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Brand NameEEA
Type of DevicePLATE, BASE, SHELLAC
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer (Section G)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key7907992
MDR Text Key121704677
Report Number2647580-2018-04697
Device Sequence Number1
Product Code EEA
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRIEEA28MT
Device Catalogue NumberTRIEEA28MT
Device Lot NumberP8A0976X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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