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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG & CO KG SHAFT COMPL.D:5MM L:310MM; CLIP APPLIER SHAFT
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AESCULAP AG & CO KG SHAFT COMPL.D:5MM L:310MM; CLIP APPLIER SHAFT Back to Search Results
Model Number PL522R
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).During intervention with davinci robot; four clips fell into the pt and had to be recovered.This resulted in surgical delay.Related medwatchs: 2916714-2015-00288; 2916714-2015-00289; and 2916714-2015-00290.
 
Manufacturer Narrative
Us reporting agent notified on: (b)(4) 2015.Reported device is not registered for use in the united states; however, similar devices are.The device was found to be twisted.This is the result of mechanical overload.The twisting led to the clips falling off when being applied.No material or mfg defects were found.
 
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Brand Name
SHAFT COMPL.D:5MM L:310MM
Type of Device
CLIP APPLIER SHAFT
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
nicole broyles
615 lambert pointe dr
hazelwood, MO 63042
3145515988
MDR Report Key4674020
MDR Text Key5669723
Report Number2916714-2015-00287
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
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 04/06/2015
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 NumberPL522R
Device Catalogue NumberPL522R
Initial Date Manufacturer Received 11/05/2014
Initial Date FDA Received04/06/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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