MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFT10GEN

Device Problem Unintended Power Up (1162)

Patient Problems Burn(s) (1757); Edema (1820); Thrombosis (2100); Claudication (2550); Blood Loss (2597); No Code Available (3191)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopy for endometriosis, the unit was used with the monopolar chain, using another bipolar clamp and pasting the patient plate on the patient.When the surgeon approached the tips of the forceps to introduce the instrument into the orifice of the abdomen, the forceps were manually and accidentally activated in the cutting mode, reaching the abdominal wall and the right iliac vein.When the surgeon took three samples from the endometrium for anatomopathological examination, they noticed smoke coming out of the orifice and called the nurse at the surgical unit.When the nurse got close to the electrocautery's energy source, it was identified that it was a bipolar clamp mounted on a monopolar chain, immediately undoing the exchange.The patient had bleeding more than 500cc and a burn.The surgeon remained clamping the vein until the arrival of the other doctors who sutured the vein, correcting the bleeding.The surgery was converted to the laparotomy procedure.The day after the procedure, after performing an echodoppler of the right lower limb, the patient was diagnosed with deep venous thrombosis, presenting edema in the thigh and claudication when walking.The patient was hospitalized for 5-7 days.

Manufacturer Narrative

Additional information: g4, h3, h6 h3.Evaluation summary: the product sample was not returned to the post market vigilance laboratory; however, a video was provided by the customer for analysis.The video sample showed that another bipolar clamp was using in monopolar 2 to activate the cutting mode.Without the sample a detailed investigation could not be performed.The file will be closed as unconfirmed at this time.If additional information is obtained, or the sample is returned, we will re-open this investigation.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9765299
• MDR Text Key: 181558302
• Report Number: 1717344-2020-00209
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR