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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AND CO. KG YASARGIL TEMP MINI-CLIP STR 7MM
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AESCULAP AG AND CO. KG YASARGIL TEMP MINI-CLIP STR 7MM Back to Search Results
Model Number FE721K
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).During placement of the clip at the aneurysm, it did not completely close.Clip was removed and replaced by a functional clip.
 
Manufacturer Narrative
(b)(4).Us reporting agent notified on (b)(4) 2014.Mfg site eval: all permanent clips are tested regarding their closing force.The date of the affected batch was reviewed and found to be fully according to the specifications.There are no hints for material or product deviations.
 
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Brand Name
YASARGIL TEMP MINI-CLIP STR 7MM
Manufacturer (Section D)
AESCULAP AG AND CO. KG
tuttlingen DE 78532
Manufacturer (Section G)
AESCULAP AG AND CO. KG
po box 40
tuttlingen 7850 1
GM   78501
Manufacturer Contact
michelle link
615 lambert pointe dr.
hazelwood, MO 63042
3145515938
MDR Report Key3883155
MDR Text Key16182703
Report Number2916714-2014-00092
Device Sequence Number1
Product Code HCH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K833650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFE721K
Device Catalogue NumberFE721K
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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