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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM 60 STAPLER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
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INTUITIVE SURGICAL, INC. SUREFORM 60 STAPLER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480460
Device Problems Entrapment of Device (1212); Device Slipped (1584); Misfire (2532); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 03/17/2021
Event Type  malfunction  
Event Description
During a roux-en-y gastric bypass case, the sureform 60 stapler misfired. The stapler had already been used about four times without incident. During the last firing, it was as if it "slipped" and did not complete the process. Once removed from the patient, team member was unable to remove the fired blue staple load. Another sureform 60 stapler was called for from case carts and the defective one was removed from the sterile field. The malfunctioning stapler will be returned to manufacturer for inspection.
 
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Brand NameSUREFORM 60 STAPLER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key11552802
MDR Text Key241757572
Report Number11552802
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 Risk Manager
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480460
Device Catalogue Number480460
Device Lot NumberL92201102021
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2021
Event Location Hospital
Date Report to Manufacturer03/23/2021
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? No
Type of Device Usage Unkown

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