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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO GRASP* 5MM INSTRUMENT FORCEPS, OBSTETRICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO GRASP* 5MM INSTRUMENT FORCEPS, OBSTETRICAL Back to Search Results
Model Number 173030
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, during a myomectomy, one sheet of the jaw of the instrument was broken. One piece of the jaw fall into the cavity, the doctor use another endo grasp to retrieve the piece of the jaw.
 
Manufacturer Narrative
(b)(4). Post market vigilance (pmv)and engineering led an evaluation of one device opened by the account. This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering evaluation, and an evaluation of the returned device. One of the jaws was disengaged from the device. A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture. Replication of damaged disengaged jaw condition may occur due to extreme handling during the application, as when too much force and excessive leverage is applied. Based on the product analysis, the failure was confirmed to be attributed to the reported event. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
 
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Type of DeviceFORCEPS, OBSTETRICAL
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
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5720257
MDR Text Key47227969
Report Number2647580-2016-00317
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
PMA/PMN Number
K903205
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number173030
Device Catalogue Number173030
Device Lot NumberP5C1051X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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