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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRAUMATIC LAPAROSCOPIC GRASPER 8360-10; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
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AESCULAP INC. PRESTIGE ATRAUMATIC LAPAROSCOPIC GRASPER 8360-10; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC Back to Search Results
Model Number 8360-10
Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 05/18/2021
Event Type  Injury  
Event Description
During case the laparoscopic instrument, an atraumatic grasper, double action, rotatable 5mm aesulap prestige 8360-10 failed to close correctly and was stuck in the open state.Upon moving the hand/trigger piece of the atraumatic grasper instrument the top part of the grasper broke off the instrument, falling into the abdomen.Surgeon attempted to retrieve broken piece with another instrument but was unsuccessful and procedure was converted to a exploratory laparotomy.Procedure for ectopic pregnancy.Fda safety report id# (b)(4).
 
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Brand Name
PRESTIGE ATRAUMATIC LAPAROSCOPIC GRASPER 8360-10
Type of Device
LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
Manufacturer (Section D)
AESCULAP INC.
center valley PA 18034
MDR Report Key11900869
MDR Text Key253542611
Report NumberMW5101609
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 05/26/2021
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? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/27/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age36 YR
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