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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL FAVALORO-MORSE STERN RET SHORT; RETRACTOR
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TELEFLEX MEDICAL FAVALORO-MORSE STERN RET SHORT; RETRACTOR Back to Search Results
Catalog Number 341163
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2015
Event Type  malfunction  
Event Description
Alleged event: the physician placed the swanson retractor into the chest cavity.He opened the retractor to gain access to the field.As he spread the blades, the handle broke.They were unable to get the retractor out at the time due to the cannulas being in the heart.When the physician was finished with the surgery the retractor was removed.All of the pieces were intact and accounted for.A chest x-ray was taken before the pt left the room to confirm all pieces were retrieved.
 
Manufacturer Narrative
Qn # (b)(4).The device sample has not been returned to the mfr for investigation at the time of this report.The mfr will continue to monitor and trend related events.
 
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Brand Name
FAVALORO-MORSE STERN RET SHORT
Type of Device
RETRACTOR
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck dr.
research triangle park NC 27709
Manufacturer Contact
effie jefferson, ra
3015 carrington mill blvd
morrisville, NC 27560
9194332672
MDR Report Key4611491
MDR Text Key5653731
Report Number1044475-2015-00126
Device Sequence Number1
Product Code EIG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Type of Report Initial
Report Date 03/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number341163
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Patient Sequence Number1
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