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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 Device Operates Differently Than Expected (2913)
Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, during a laparoscopic endometrial cancer extirpation, upon clamping fat of mesentery, the jaws fixed in the closing position, and did not open. Fat was resected to remove the device from the 5 mm port. No patient harm and tissue damage has been reported since the resected tissue was fat.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation 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. The ratchet switch was disengaged. The rotation knob functioned without difficulty. The jaws were opened and closed, and grasped media without difficulty. 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 quality release specifications at the time of manufacture. Replication of the secondary blades indicates that the instrument may have been exposed to an external force which bent the exposed metal bars. 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 Key5585054
MDR Text Key42918343
Report Number2647580-2016-00168
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,Followup,Followup,Followup
Report Date 04/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2016
Is this an Adverse Event Report? Yes
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 Manufacturer05/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/18/2016 Patient Sequence Number: 1
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