MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. PUSH-BUTTON ELECTROSURGICAL PENCIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 88-000002

Device Problem Electronic Property Issue (2928)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 11/26/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating an electrosurgical pencil fired randomly, causing a burn to a patient.The defective sample was thrown away and not available for return.The investigation is ongoing as of the date of this report.When new and critical information becomes available, this report will be updated.

Event Description

The cautery pencil fired randomly and a patient suffered a burn in the middle of their chest.

Manufacturer Narrative

Root cause: a root cause is unable to be determined.No issues were found in the documentation on hand, and a defective sample was not returned for evaluation.Corrective action: no corrective actions were taken due to the root cause determination.Investigation summary: an internal complaint ((b)(4)) was received indicating an electrosurgical pencil fired randomly, causing a burn to a patient.The defective sample was thrown away and not available for return.The device history record for the reported lot number (45316121) was reviewed and no issues were detected during the manufacturing process.The sub-assembly work orders assigned to the finished product also were reviewed.No rejects were reported in the continuity test results.Additionally, no issues were detected during work order in process.The last two closed work orders for part number 88-000002cr (the pencil sub-assembly) were reviewed and no rejects were reported during the manufacturing process.A review of past complaints for two years was conducted and no similar issues have been reported.Preventive action: a preventive action has not been taken due to the root cause determination.The investigation is complete.If new and critical information becomes available, this report will be updated.

Event Description

The cautery pencil fired randomly and a patient suffered a burn in the middle of their chest.

• Brand Name: PUSH-BUTTON ELECTROSURGICAL PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 7154138
• MDR Text Key: 96621405
• Report Number: 9613793-2017-00008
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-000002
• Device Lot Number: 45316121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1