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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CLIP APPLIER/REMOVER D:12.5/350MM LIGATION / VESSEL CLIPS

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AESCULAP AG CLIP APPLIER/REMOVER D:12.5/350MM LIGATION / VESSEL CLIPS Back to Search Results
Model Number PL531R
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with pl531r - clip applier/remover d:12. 5/350mm. According to the complaint description, the tip of the device was chipped during surgery. The damaged pieces were collected immediately and the surgery was completed without any problems. The cause may be that the tip was caught when it was removed, so it may have been pulled or contacted with forceps. Additional information was not provided. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameCLIP APPLIER/REMOVER D:12.5/350MM
Type of DeviceLIGATION / VESSEL CLIPS
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11843489
MDR Text Key262693554
Report Number9610612-2021-00379
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K992053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPL531R
Device Catalogue NumberPL531R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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