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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG & CO. KG CROSS SLIT VALVE FOR 10/12MM TROCARS; TROCAR ACCESSORY
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AESCULAP AG & CO. KG CROSS SLIT VALVE FOR 10/12MM TROCARS; TROCAR ACCESSORY Back to Search Results
Model Number EK084P
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Tear on valve below the trocar.Operation time was extended due to necessary replacement of device due to leakage of the seal.
 
Manufacturer Narrative
Reporting agent in the us notified on (b)(6) 2015.Manufacturing site investigation: received seal units show cracks.Root cause is damage by sharp object; user related.These products are tested at 100% regarding their intactness before they ae sent to stock.Therefore a failure in manufacturing is excluded.There are no indications of product or material deviations.Reported device is an accessory part of reuseable trocar system.Trocar system procode is (b)(4).
 
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Brand Name
CROSS SLIT VALVE FOR 10/12MM TROCARS
Type of Device
TROCAR ACCESSORY
Manufacturer (Section D)
AESCULAP AG & CO. KG
tuttlingen DE 78532
Manufacturer (Section G)
AESCULAP AG & CO KG
p.o. box 40
tuttlingen
GM  
Manufacturer Contact
nicole broyles
615 lambert pointe dr.
hazelwood, MO 63042
3145515988
MDR Report Key4862128
MDR Text Key5847687
Report Number2916714-2015-00492
Device Sequence Number0
Product Code NWV
Reporter Country CodeFR
PMA/PMN Number
NARRATIVE
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 06/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEK084P
Device Catalogue NumberEK084P
Initial Date Manufacturer Received 01/28/2015
Initial Date FDA Received06/17/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Patient Sequence Number1
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