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

MAUDE Adverse Event Report: AESCULAP, INC. ATRAUMATIC GRASPER LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • 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, INC. ATRAUMATIC GRASPER LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number M49435
Device Problems Break (1069); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2020
Event Type  Malfunction  
Event Description

Surgeon unable to close jaws of davis and geck grasper. Gasper then broke inside patient. 8mm trocar was placed and two small pieces were retrieved.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATRAUMATIC GRASPER
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
AESCULAP, INC.
3773 corporate pkwy
center valley PA 18034
MDR Report Key9902616
MDR Text Key185708912
Report Number9902616
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/12/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM49435
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/12/2020
Event Location Hospital
Date Report TO Manufacturer03/31/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-