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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. SINGLE-SITE CROCKODILE GRASPER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL INC. SINGLE-SITE CROCKODILE GRASPER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 478059
Device Problems Crack (1135); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 07/02/2021
Event Type  malfunction  
Event Description
Patient was undergoing robotic assisted single site cholecystectomy. While in use inside of the patient, a plastic piece cracked, and the jaw assembly of the instrument fell apart. All pieces were retrieved from the patient.
 
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Brand NameSINGLE-SITE CROCKODILE GRASPER
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12216812
MDR Text Key263132399
Report Number12216812
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
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 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number478059
Device Catalogue Number478059
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2021
Event Location Hospital
Date Report to Manufacturer07/23/2021
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?
Type of Device Usage Unkown

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