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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION; INSUFFLATOR, LAPAROSCOPIC
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STRYKER CORPORATION; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Model Number 0620030407
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) with bilateral salpingectomy.At the time of skin closure, a red area (approximately 3 inches x 1 inch) was noted on the right lower abdomen in a location, which was touched by the high flow heated insufflator tubing.The tubing was still connected to the insufflator, but was no longer on.The tubing was warm to touch despite no longer in use for approximately 10 minutes.Manufacturer response for high flow heated insufflator tubing, high flow heated insufflator tubing (per site reporter): a stryker on-site field specialist was made aware of the event and responded by validating that all high flow heated insufflator tubing of like lot# were removed from inventory.
 
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Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct.
san jose CA 95138
MDR Report Key6732165
MDR Text Key80679055
Report Number6732165
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 Number0620030407
Device Catalogue Number620-030-407
Device Lot Number17119FE2
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
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
HIGH FLOW HEATED INSUFFLATOR TUBING WAS ATTACHED T
Patient Outcome(s) Other;
Patient Age40 YR
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