Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG & CO. KG YASARGIL TI PERM STD - CLIP STR 17.5 MM; VASCULAR CLIP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG & CO. KG YASARGIL TI PERM STD - CLIP STR 17.5 MM; VASCULAR CLIP Back to Search Results
Model Number C
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 07/13/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Complaint states: during an operation, the surgeon confirmed by an image that the clip was fixed an aneurysm properly.Then, after the operation, he confirmed with a ct as well.However, the patient's condition began to deteriorate.The surgeon decided to do a 3d cta.As a result, it was confirmed that the clip had slipped out from the aneurysm.The surgeon reoperated and changed to a sugita clip.
 
Manufacturer Narrative
Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: evaluation is ongoing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
YASARGIL TI PERM STD - CLIP STR 17.5 MM
Type of Device
VASCULAR CLIP
Manufacturer (Section D)
AESCULAP AG & CO. KG
tuttlingen 7853 2
GM  78532
Manufacturer (Section G)
AESCULAP AG&CO KG
po box 40
tuttlingen 7850 1
GM   78501
Manufacturer Contact
michelle link
615 lambert pointe dr.
hazelwood, MO 63042
3145515938
MDR Report Key4213833
MDR Text Key5035842
Report Number2916714-2014-00658
Device Sequence Number1
Product Code HCH
Combination Product (y/n)N
PMA/PMN Number
K002871
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 08/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC
Device Catalogue NumberC0068558
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2014
Date Device Manufactured03/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
-
-