Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE Back to Search Results
Model Number RELTACK8RDPTSW
Medical Device Problem Codes Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 08/14/2019
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 a laparoscopic umbilical hernia procedure, while working on the abdomen, surgeon experienced difficulties with loading the reload onto the handle.It was also noted that the reload fell into the patient's cavity.Surgeon opened new device to complete the case.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RELIATACK
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8975037
Report Number1219930-2019-05076
Device Sequence Number10840617
Product Code GDW
UDI-Device Identifier20884521726359
UDI-Public20884521726359
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K151659
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) 09/09/2019
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 NumberRELTACK8RDPTSW
Device Catalogue NumberRELTACK8RDPTSW
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2019
Initial Report FDA Received Date09/09/2019
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 Other;
Patient Age65 YR
-
-