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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST PROGRASP FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST PROGRASP FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471093
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 06/14/2022
Event Type  malfunction  
Event Description
While using the xi prograsp, doctor noted that it would no longer open and close and that was when it was noticed that one of the cables was broken.
 
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Brand NameENDOWRIST PROGRASP FORCEPS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key14874229
MDR Text Key295055630
Report Number14874229
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 06/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number471093
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2022
Event Location Hospital
Date Report to Manufacturer06/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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