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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INITIATIVE SURGICAL DA VINCI XI SUREFORM STAPLER RELOAD

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INITIATIVE SURGICAL DA VINCI XI SUREFORM STAPLER RELOAD Back to Search Results
Model Number 48360G-08
Device Problems Defective Component (2292); Device Issue (2379)
Patient Problem Impaired Healing (2378)
Event Date 07/01/2019
Event Type  Injury  
Event Description
Pt had robotic assisted sleeve gastrectomy possible open procedure on (b)(6) 2019. "pt returned to surgery for post-op bleed on the pt in question. " on (b)(6) 2019 pt discharged home. Hosp received recall on july 11, 2019 for select lot numbers of green and black sureform 60 staple loads. Pt is readmitted on (b)(6) 2019 with severe abdominal pain. Endoscopy was performed, which revealed a substantial gastric leak. Pt was placed in icu and is improving.
 
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Brand NameDA VINCI XI SUREFORM STAPLER RELOAD
Type of DeviceSTAPLER RELOAD
Manufacturer (Section D)
INITIATIVE SURGICAL
sunnyvale CA
MDR Report Key8842096
MDR Text Key152832574
Report Number8842096
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 Administrator/Supervisor
Type of Report Initial
Report Date 07/23/2019,07/11/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48360G-08
Device Catalogue Number48360G-08
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/23/2019
Distributor Facility Aware Date07/11/2019
Event Location Hospital
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: 07/24/2019 Patient Sequence Number: 1
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