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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE
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COVIDIEN MEDICAL PRODUCTS PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE Back to Search Results
Model Number 111989
Medical Device Problem Codes Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
Date of Event 07/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during anastomosis on a laparoscopic colon procedure, there was a poor staple formation.It was stated that excessive tissue incorporated into the barrel of the stapler.The donuts were also not complete.Another device and sewing was done to fix the staple line.
 
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Brand Name
PREMIUM PLUS CEEA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN MEDICAL PRODUCTS
building 10- no 789 puxing roa
shanghai 20111 4
CH  201114
MDR Report Key12239968
Report Number3006451981-2021-00098
Device Sequence Number14496272
Product Code GDW
UDI-Device Identifier10884523006612
UDI-Public10884523006612
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K001895
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/28/2021
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 Number111989
Device Catalogue Number111989
Device Lot NumberS7AC001X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2021
Initial Report FDA Received Date07/28/2021
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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