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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION GS2000 INSUFFLATOR
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CONMED CORPORATION GS2000 INSUFFLATOR Back to Search Results
Model Number 50L INSUFFLATOR
Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)
Patient Problems Therapeutic Effects, Unexpected (2099); Abdominal Distention (2601)
Event Date 07/29/2016
Event Type  Injury  
Event Description
The pneumoperitoneum was then hooked up through the port.In the usual fashion we attempted to insufflate the abdomen to 15 mmhg, which the settings were confirmed on insufflation machine.Her abdomen became distended and we noticed after a few seconds that it was over distended and that we were having difficulty ventilating the pt all of a sudden.The abdomen was very rigid.After a few seconds, we evacuated the pneumoperitoneum.The insufflation was stopped.At this point we realized that the insufflator had malfunctioned and the pt had received a greater than desired amount of co2 to the abdomen and there had been extravasation of the co2 into her tissue planes on her chest wall, up into her scalp, face causing crepitus throughout.(b)(4).
 
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Brand Name
GS2000 INSUFFLATOR
Type of Device
GS2000 INSUFFLATOR
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key5852998
MDR Text Key51468515
Report NumberMW5063880
Device Sequence Number1
Product Code FCX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50L INSUFFLATOR
Device Catalogue NumberGS2000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight66
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