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

Model Number FT10

Device Problem Power Problem (3010)

Patient Problems Bowel Burn (1756); Bowel Perforation (2668)

Event Date 09/22/2021

Event Type  Injury  

Event Description

The patient was undergoing a laparoscopic supracervical hysterectomy and sacrocolpopexy.During the step in which the uterus is transected from the cervix, the surgeon used a lina loop which is a commonly used, disposable, monopolar instrument.The lina loop requires higher cutting power than is used for other surgical instruments.Prior to using the loop, the surgeon requested the cut power setting to be increased to 120.After the loop was used, the monopolar power cord was attached to the re-usable, laparoscopic scissors but the power setting was not reduced.The monopolar scissors were activated for a ~10 seconds before the surgeon asked whether the power had been lowered to the appropriate setting for the scissors (30-40).The power was reset and the case continued.At the end of the surgery, the surgeon noted a small white area on the small bowel in the upper abdomen that he thought was an electrosurgical energy burn.He consulted a general surgeon and they performed a resection of this area of small bowel and found that the remaining bowel was unaffected.The patient was discharged the next day, feeling well.On post-op day #5, she presented to her local hospital with signs and symptoms of a small bowel obstruction.Her clinical presentation and imaging was concerning for a bowel perforation.She returned to the operating room and 3 additional bowel perforations were identified and repaired by resecting a length of jejunum.The initial bowel anastomosis was intact and patent.The surgeon believes the laparoscopic monopolar scissors, not the lina loop, "leaked" the electrosurgical energy that caused the thermal bowel injury.It is unclear whether the higher power setting (120 vs 40) contributed to the complication.Spread of electrosurgical energy to a non-targeted tissue is known to occur with all types of monopolar instruments.The time course for this patient to re-present with additional bowel perforations is typical for the delayed tissue necrosis that occurs with a thermal injury.The scissors instrument was identified and located.The instrument was tested with a mcgan insulation tester and no defects in the insulation were found.It appears capacitive coupling transferred enough energy to cause the burn.It would be great if the electrosurgical generator had a feature that would reset the power to a low level anytime an accessory was changed.

• Brand Name: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13994616
• MDR Text Key: 288502375
• Report Number: 13994616
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FT10
• Device Catalogue Number: FT10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 24455 DA
• Patient Sex: Female