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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. SUREFORM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480460
Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2022
Event Type  malfunction  
Event Description
Staple load failure with resulting leak requiring two subsequent surgical interventions. Surgeon was proceeding with robotic revision roux-en-y and fired a blue 60mm staple load using the sureform 60 endoscopic motorized cutting stapler. Upon stapler completion, it was noted that staple load had cut tissue but not stapled on either side of cut causing gastric contents to leak out. A subsequent 60mm blue load was used to complete the intended cut. After this was done, surgeon noted pancreatic tissue near area of subsequent cut/staple. Doctor then verbalized concern that pancreatic injury may have occurred. Another surgeon was consulted and came to verify that no pancreatic injury had indeed occurred. Retroperitoneal tissue was sent to pathology to verify. Repair of gastroesophageal junction due to failed stapler load was completed.
 
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Brand NameSUREFORM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key14186328
MDR Text Key289875252
Report Number14186328
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480460
Device Lot NumberT90211201
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2022
Date Report to Manufacturer04/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/22/2022 Patient Sequence Number: 1
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