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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.; LIGATURE CLIPS MULTI-FIRE

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AESCULAP AG CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.; LIGATURE CLIPS MULTI-FIRE Back to Search Results
Model Number PL579T
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6).Intra-operative clip function deviation.During a prostatectomy with robot some of the clips bent and didn't hold on to the tissues.Applier reported below.Challenger ti-p handle_product (b)(4) & shaft compl.D:10mm l:370mm_product (b)(4).
 
Manufacturer Narrative
(b)(4).Manufacturing site evaluation: the received clips have several bruises on the surface and they are severely deformed.The clips were analyzed by microscope.Attempts to recreate the complaint were made; in order to get the described error, the applicator had to be rotated approximately 90 degrees before or during the application progress.This resulted in parts of the jaw being pushed apart, which severly deformed the ligature clip.A review of the device quality and manufacturing history records was not possible, as the lot number is unknown.Based on the information available as well as a result of the investigation, the root cause of the failure is most likely user related.Corrective / preventive action(s) is not necessary.
 
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Brand Name
CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.
Type of Device
LIGATURE CLIPS MULTI-FIRE
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM   78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key5114964
MDR Text Key27176800
Report Number2916714-2015-00844
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPL579T
Device Catalogue NumberPL579T
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/09/2015
Initial Date FDA Received09/30/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/30/2015
Was Device Evaluated by Manufacturer? No
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) Other;
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