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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VALLEYLAB FT10; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE

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COVIDIEN VALLEYLAB FT10; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE Back to Search Results
Catalog Number VLFT10GEN
Device Problems Fire (1245); Overheating of Device (1437); Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2019
Event Type  malfunction  
Event Description
A raytec caught on fire during the surgical procedure.At approximately 1520 during the procedure, the surgical resident was retracting tissue with senn retractors while the attending surgeon utilized a bovie; when a raytec in the resident's hand heated up, smoked and ultimately caught on fire.The resident pulled the raytec away from the patient and noticed that it was smoking.He brought it even further from the drapes, towards the foot of the bed and notified the circulator nurse.When the circulator nurse saw the raytec in his hand, it was on fire.The circulator told the resident to drop the flaming raytec on a clear area on the floor.The circulator then asked the scrub to put out the fire using the saline on her field.The scrub sprayed saline on the raytec on the ground using an asepto bulb syringe from her field.The resource nurse was informed at 1524.After putting out the fire and before the resource nurse was notified, the patient was initially assessed for any injury or burns by the surgical attending and surgical resident.The drapes were looked at for any signs of burns.A bovie holster was used throughout the case and held the bovie when it was not in use.Prior to the application of dressings, the patient's skin was examined at 1607 again by the surgical attending, surgical resident and circulator nurse.Prior to the application of webril and cast the skin was examined 1 more time by the surgical attending, surgical resident, and circulator nurse.During all skin examinations, the team saw that the skin was free of any injury or burns.The circulator nurse removed the bovie pad at 1613 and the bovie pad site was clear, and intact.Bovie machine number: 59218 bovie pad lot number: 92030095 bovie setting: cut-20 coag-30 spoke with the staff involved to obtain more details.Per the surgical tech and scrub nurse the surgeon and resident were utilizing the bovie in the correct way and it was not in direct contact with the raytec sponge that caught fire.The resident was holding the raytec with the same had that was used to hold the retractor.The bovie was in use near the retractor which may have been a possible conductor of an electric current or spark that may have led to this incident.More information is needed.The staff did exactly what they needed to do to prevent a burn injury to the patient once it was seen that the raytec was smoking.Quick action by the resident, nurse, and scrub tech prevented further spread of fire.
 
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Brand Name
VALLEYLAB FT10
Type of Device
SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key9309550
MDR Text Key165971379
Report Number9309550
Device Sequence Number1
Product Code OCL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVLFT10GEN
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2019
Event Location Hospital
Date Report to Manufacturer11/12/2019
Type of Device Usage N
Patient Sequence Number1
Patient Age4745 DA
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