• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AESCULAP PRESTIGE GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

  • 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 AESCULAP PRESTIGE GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC Back to Search Results
Model Number 8360-10
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
Tip of the laparoscopic grasper broke.Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AESCULAP PRESTIGE GRASPER
Type of Device
LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
Manufacturer (Section D)
AESCULAP
center valley PA 18034
MDR Report Key11462337
MDR Text Key239447233
Report NumberMW5099920
Device Sequence Number1
Product Code NWV
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/08/2021
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 Number8360-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/10/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
Patient Weight60
-
-