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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAPAROSCOPIC / ROBOTIC STAPLER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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LAPAROSCOPIC / ROBOTIC STAPLER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Defective Device (2588)
Patient Problem Unspecified Infection (1930)
Event Date 12/08/2021
Event Type  Injury  
Event Description
Return to surgery for infected mesh with phasix implantation, bowel obstructions and s/p explantation of infected ventralight mesh with phasix. According to the op note dated (b)(6) 2021. The proximal and distal limbs of intestine were then aligned with stay sutures so that a side-to-side stapled anastomosis could be performed at the antimesenteric border of the intestine. Ultimately a laparoscopic stapler was used to create the anastomosis as the robotic stapler had a malfunction preventing it from clamping. The opening in small bowel was closed in two layers using 2-0 v-lock in a running fashion. The mesenteric defect was also closed using the end of this suture. Also during the case on (b)(6) 2021, while in step trendelenburg and airplaned left, he slid on the table which required repositioning of him and the robot. Robotic stapler was sent to intuitive.
 
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Brand NameLAPAROSCOPIC / ROBOTIC STAPLER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key13118139
MDR Text Key283092976
Report NumberMW5106364
Device Sequence Number2
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 Risk Manager
Type of Report Initial
Report Date 12/27/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
Treatment
2-0 V-LOCK SUTURE
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