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 SHAFT COMPL.D:10MM L:370MM; LIGATION / VESSEL CLIPS
  • 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 SHAFT COMPL.D:10MM L:370MM; LIGATION / VESSEL CLIPS Back to Search Results
Model Number PL536R
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 12/17/2020
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 pl536r - shaft compl.D:10mm l:370mm.According to the complaint description, the applier is broken at the opening.The clips are deflected and do not clip in the desired location while the patient has arterial bleeding.An additional medical intervention was necessary.Additional information was not provided nor available was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00090 (b)(4) + pl520r), 9610612-2020-00998, (b)(4) + pl520r).
 
Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHAFT COMPL.D:10MM L:370MM
Type of Device
LIGATION / VESSEL CLIPS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key11568913
MDR Text Key256454607
Report Number9610612-2021-00192
Device Sequence Number1
Product Code OCW
Combination Product (y/n)N
PMA/PMN Number
K962493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPL536R
Device Catalogue NumberPL536R
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-