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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP GRASPERS GALLBLADDER GRASPER

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AESCULAP, INC. AESCULAP GRASPERS GALLBLADDER GRASPER Back to Search Results
Model Number 8360-10
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Internal Organ Perforation (1987)
Event Date 11/10/2015
Event Type  Injury  
Event Description

Gallbladder grasper did not grasp which resulted in the surgeon puncturing the gallbladder.

 
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Brand NameAESCULAP GRASPERS
Type of DeviceGALLBLADDER GRASPER
Manufacturer (Section D)
AESCULAP, INC.
3773 corporate parkway
center valley PA 18034
MDR Report Key5263358
MDR Text Key32665062
Report Number5263358
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8360-10
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/25/2015
Distributor Facility Aware Date11/18/2015
Device Age na
Event Location Hospital
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/25/2015 Patient Sequence Number: 1
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