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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 Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Initial reporter phone number: (b)(6). Contact office phone number: (b)(4).
 
Event Description
According to the reporter, during a lap chole the handle just fell apart in the clinician¿s hand.
 
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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 
MDR Report Key6192711
MDR Text Key62918232
Report Number2647580-2016-01130
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 11/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model Number173030
Device Catalogue Number173030
Device Lot NumberP6E0320X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2016
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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