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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device has not been received. A supplemental report will be sent if device is received.
 
Event Description
According to the reporter, during a gynecological procedure, the surgeon used the product, and the product broke. There was no damage to the patient. The surgery was completed with no further problems. There was no reinforcement material used. There was no tissue loss. There was no extension of the incision over i one inch. There was no bleeding over 500ccs. There was no delay in time over 30 minutes.
 
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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
matthew amaral
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key5924262
MDR Text Key53793784
Report Number2647580-2016-00668
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K121510
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 08/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model Number174317
Device Catalogue Number174317
Device Lot NumberP5K0185X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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