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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG & CO KG XS APPL.FCPS.MINI TI.90/230MM; ANEURYSM CLIP APPLIER
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AESCULAP AG & CO KG XS APPL.FCPS.MINI TI.90/230MM; ANEURYSM CLIP APPLIER Back to Search Results
Model Number FT490T
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).The surgeon grasped the cerebral aneurysm by clip, and then tried to fix the position of the clip again, however, the clip applier did not work properly.The blades of the clip could not be opened.The surgeon was successfully able to remove the applier from the clip without harming the aneurysm.Surgery delay greater than 15 minutes.
 
Manufacturer Narrative
U.S.Reporting agent notified on: (b)(4) 2015.Mfg site eval: eval on-going at mgf site.
 
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Brand Name
XS APPL.FCPS.MINI TI.90/230MM
Type of Device
ANEURYSM CLIP APPLIER
Manufacturer (Section D)
AESCULAP AG & CO KG
tuttlingen DE 78532
Manufacturer (Section G)
AESCULAP AG & CO KG
po box 40
tuttlingen
GM  
Manufacturer Contact
nicole broyles
615 lambert pointe dr
hazelwood, MO 63042
3145515988
MDR Report Key4618021
MDR Text Key22151433
Report Number2916714-2015-00201
Device Sequence Number1
Product Code HCI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFT490T
Device Catalogue NumberFT490T
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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