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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 FORCEPS, OBSTETRICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLINCH* II 5MM INSTRUMENT FORCEPS, OBSTETRICAL Back to Search Results
Model Number 174317
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Since the lot number was not provided, this information cannot be determined. Evaluation summary: post market vigilance (pmv) with engineering led an evaluation of one received one device opened by the account. The 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. Engineering noted that the housing appeared to be partially split where the shaft meets the handle. The unit was disassembled for evaluation. Proper welding was observed: all energy directors were properly melted. Brownish particles were observed adhered to the center rod, which prevented the center rod to have a free movement transition during actuation. Thus affecting opening/closing of jaws during application. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. A review of the device history record could not be performed because the lot number was not provided. However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture. Replication of the reported condition may occur when some type of fluid solidifies inside the center rod thus causing the needle to get stuck during deployment. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
 
Event Description
According to the reporter, during surgery, the handle could not be squeezed anymore. The event occurred in use for patient. The procedure was completed with another device. The status of the patient: no problem. The patient gender is not available. The patient age is not available. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use.
 
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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 Key6361212
MDR Text Key68413976
Report Number2647580-2017-00190
Device Sequence Number1
Product Code HAD
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,u
Reporter Occupation
Type of Report Initial
Report Date 01/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number174317
Device Catalogue Number174317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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