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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO, INC. ENDO CLINCH II 5MM INSTRUMENT; SINGLE USE LAPAROSCOPIC HAND INSTRUMENT
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COVIDIEN, FORMERLY USSC PUERTO RICO, INC. ENDO CLINCH II 5MM INSTRUMENT; SINGLE USE LAPAROSCOPIC HAND INSTRUMENT Back to Search Results
Catalog Number 174317
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2013
Event Type  malfunction  
Event Description
Procedure: laparoscopic hysterectomy.According to the reporter: the ratchet came off from the device.Operating time extended: less than 30 min.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
ENDO CLINCH II 5MM INSTRUMENT
Type of Device
SINGLE USE LAPAROSCOPIC HAND INSTRUMENT
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
building 911-67
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
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key3761358
MDR Text Key16915003
Report Number2647580-2014-00006
Device Sequence Number1
Product Code HDA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K903205
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 12/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2018
Device Catalogue Number174317
Device Lot NumberP3J0147X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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