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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY SIDNE SMART 40L CORE INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC
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STRYKER ENDOSCOPY SIDNE SMART 40L CORE INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Model Number 0620040504
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 06/27/2017
Event Type  malfunction  
Event Description
The patient was undergoing a laparoscopic assisted vaginal hysterectomy (lavh)and bilateral hysterectomy.During skin closure, the patient was noted to have a red area (approximately 3 inches x 1 inch) on the right lower quadrant of the abdomen.High flow heated insufflator tubing was attached to the insufflator, which was turned off.High flow heated insufflator tubing continued to feel warm to touch.The insufflator was sequestered and the tubing of like lot# was removed from inventory.Manufacturer response for insufflator, (brand not provided) (per site reporter): stryker on-site specialist was made aware of the event.The device was sequestered at the time of the event.The device to be returned to stryker quality department for evaluation.The additional devices in the facility were all evaluated by the on-site specialist and on two additional devices the heating icon did not appear when the heated tube set was plugged i; the two additional devices were returned to stryker for evaluation.
 
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Brand Name
SIDNE SMART 40L CORE INSUFFLATOR
Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER ENDOSCOPY
5900 optical ct.
san jose CA 95138
MDR Report Key6732136
MDR Text Key80679676
Report Number6732136
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2017,07/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0620040504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2017
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2017
Event Location Hospital
Date Report to Manufacturer07/03/2017
Type of Device Usage N
Patient Sequence Number1
Treatment
HIGH FLOW HEATED INSUFFLATOR TUBING WAS ATTACHED T
Patient Age40 YR
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