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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE STAPLER

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INTUITIVE SURGICAL, INC. INTUITIVE STAPLER Back to Search Results
Lot Number T10180504-007
Device Problems Failure to Calibrate (2440); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
Event Type  Injury  
Event Description
Pt in surgery for robotic assisted right upper lung wedge resection. During course of surgery, robotic staplers were used. Staplers would not calibrate and failed. Emergency customer service for intuitive surgical inc called. Staplers removed from service and sent to central sterile for inspection. Central sterile to return to the mfr. Surgery continued with laparoscopic staplers being used by the surgeon. No harm to the pt.
 
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Brand NameINTUITIVE STAPLER
Type of DeviceSTAPLER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key7689279
MDR Text Key114177572
Report NumberMW5078384
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberT10180504-007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 07/13/2018 Patient Sequence Number: 1
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