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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 Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Patient information not provided. Udi not provided. Re-processing information not provided.
 
Event Description
According to the reporter, during a lobectomy, when lung parenchyma was set and released with the device, the root of jaws was broken. The device did not work. There were no operations which became a burden to the device. The procedure was completed with another device. The product was removed from the tissue without damaging it.
 
Manufacturer Narrative
(b)(4). Post market vigilance (pmv) led an evaluation of one endo clinch. 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, and an evaluation of the returned device. The visual inspection of the device noted the jaws were broken. The shaft snapped just proximal to the jaws. Engineering found that the tube housing was broken on both tabs; jaws were still attached to the rivet of the broken tabs. The rivet was inspected and it was found properly riveted. Replication of the broken jaws may occur when excessive manipulation of side force (leverage) by user consequently causes the breakage of the tube housing tabs. The riveted tabs hold in place the jaws; once the tube housing is broken the jaws could become loose. The file will be closed as misuse of the product. Should new information become available, the file will be re-opened and reassessed at that time.
 
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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 Key5820142
MDR Text Key50349400
Report Number2647580-2016-00521
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 07/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model Number174317
Device Catalogue Number174317
Device Lot NumberP5L0024X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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