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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. TIP COVER ACCESSORY SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. TIP COVER ACCESSORY SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 400180
Device Problems Detachment Of Device Component (1104); Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 09/06/2017
Event Type  malfunction  
Event Description
Tip cover used to protect robotic instrument during procedure came off in place for the majority of the procedure. Surg tech noted it missing when removed from the abdominal cavity. Surgeon informed. Laparoscopic search conducted, transition to hand-assisted laparoscopic, then conversion to open laparotomy to facilitate thorough cavity search. Radiology films taken and reviewed by radiologist prior to conversion to open. Tip cover not visualized on the film. Film taken of a new tip cover to provide comparison for radiologist. Tip cover not radiopaque. After tip cover reported missing, a thorough search of the room, trash and linen conducted. Abdominal ap and lateral x ray was performed and read by the on duty radiologist after which more intra-abdominal and pelvic searching was performed. At the discretion of the surgeon, searching was discontinues and the abdomen was closed. All other surgical counts were performed per policy and found to be correct. It was retrieved from the subcutaneous tissue in a separate procedure.
 
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Brand NameTIP COVER ACCESSORY
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
950 kifer rd
sunnyvale CA 94086
MDR Report Key6993617
MDR Text Key90785541
Report Number6993617
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/19/2017,10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180
Device Lot NumberM10170621
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
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