• 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

  • 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 Back to Search Results
Model Number UNKNOWN ENDO ST
Device Problem Detachment Of Device Component (1104)
Patient Problem Tissue Damage (2104)
Event Date 05/04/2017
Event Type  malfunction  
Event Description
According to the reporter: during the laparoscopic partial diaphragmatic plastic with alloplastic mesh procedure, the device was difficult to toggle. The instrument's clamping mechanism for the needle regularly fails despite proper application. The needle fell into the patient cavity and needles are partially lost in tissue. All the needles were removed and disposed of in the garbage. As a result there was a hematoma. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mc dermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mc dermott rd
north haven CT 06473
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6721770
MDR Text Key80517135
Report Number1219930-2017-06014
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 05/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN ENDO ST
Device Catalogue NumberUNKNOWN ENDO ST
Device Lot NumberUNKNOWN
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 Received05/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-