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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL CUSHING IVD RONGEUR RONGEUR, MANUAL

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TELEFLEX MEDICAL CUSHING IVD RONGEUR RONGEUR, MANUAL Back to Search Results
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 12/21/2015
Event Type  malfunction  
Event Description
During a posterior spinal fusion the physician was removing the disc using an upbiting pituitary rongeur. The tip broke off inside the patient. It took the physician an additional 20 minutes of surgery time to find and remove the tip from the patient. The pituitary rongeurs were taken out of service.
 
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Brand NameCUSHING IVD RONGEUR
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key5379211
MDR Text Key36395340
Report Number5379211
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2016
Event Location Hospital
Date Report to Manufacturer01/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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