MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. EXTENDEVAC ELECTROSURGICAL PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 88-00072

Device Problems Self-Activation or Keying (1557); Failure to Read Input Signal (1581); Failure to Shut Off (2939)

Patient Problem Burn, Thermal (2530)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

Unintentional activation of a deroyal extendevac electrosurgical pencil ref: 88-00072.Four incidents reported regarding this product malfunction, two have resulted in injury to patients (burns to thigh and breast) and two near miss events.First incident: it was noticed that the electrosurgical pencil was activating while not in use and caused a burn approximately 2.5 cm to the patient's left anterior thigh.The burn was excised, the incision was closed and dressed with steri-strips and a mepilex dressing.Second incident: at the beginning of the case, the surgeon started using the bovie (deroyal extendedvac electrosurgical pencil (ref 88-000722, lot 50071481) and as he finished using it, the bovie pencil did not turn off.The device was unplugged from the machine and re-plugged and still buzzed as if it was burning tissue, but in fact it was turned off at the hand piece.No patient harm.Third incident: event reported at another facility: the cautery pencil remained active without finger control activating the pencil.It was set on the patient and unintentionally caused a burn to the patient's breast.The cautery defect was replicated immediately after the event in the o.R by the surgeon.It was taken out of service and a new cautery pencil was obtained.A product concern was initiated.Extendvac electrosurgical pencil ref#88-000722, lot#49031182.Fourth incident: the coag button on the cautery pencil remained activated even though the surgeon wasn't pressing the button.No patient involved.

• Brand Name: EXTENDEVAC ELECTROSURGICAL PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 8960649
• MDR Text Key: 156493099
• Report Number: 8960649
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 88-00072
• Device Lot Number: 49031182,50071481
• 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: 07/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 93