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, FORMERLY USSC PUERTO RICO, INC. ENDO RETRACT*MAXI 10MM INST(ROTICULATOR); SINGLE USE LAPAROSCOPIC HAND INSTRUMENT
  • 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, FORMERLY USSC PUERTO RICO, INC. ENDO RETRACT*MAXI 10MM INST(ROTICULATOR); SINGLE USE LAPAROSCOPIC HAND INSTRUMENT Back to Search Results
Catalog Number 174311
Device Problems Difficult to Remove (1528); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2011
Event Type  malfunction  
Event Description
Procedure: thoracic.According to the reporter: the tip would not retract back into the device.It was difficult to remove through the trocar.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SINGLE USE LAPAROSCOPIC HAND INSTRUMENT
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer (Section G)
COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer Contact
sharon murphy, qa
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key4168604
MDR Text Key5021247
Report Number2647580-2014-00564
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K914190
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/26/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2016
Device Catalogue Number174311
Device Lot NumberP1F0188X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/26/2011
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2011
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
-
-