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

Model Number	88-000006
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the defective sample was not returned for evaluation, and no issues were identified during review of internal documentation.A root cause cannot be determined.Corrective action: a corrective action was not taken due to the root cause determination.Investigation summary: an internal complaint (call (b)(4)) was received for an electrosurgical pencil (part 88-000006) that inadequately cut, resulting in the patient sustaining a burn injury to the skin.The defective device was not returned for evaluation.The device history record for the affected part was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.A continuity test is performed on the sub-assembly during manufacturing.This test verifies that the device performs cutting and coagulation functions.One work order was found in storage for the applicable sub-assembly.Eighty units were inspected and no issues were found.Internal complaints were reviewed for a period of two years for similar issues.No similar issues were identified.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
Activation of the diathermy resulted inadequate cutting that resulted in a superficial skin burn requiring excision.

• Brand Name: CAUTERY PENCIL, ROCKER
• Common Device Name: 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
• MDR Report Key: 8674506
• Report Number: 9613793-2019-00003
• Device Sequence Number: 2349885
• Product Code: GEI
• UDI-Device Identifier: 00749756134101
• UDI-Public: 00749756134101
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K961647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 88-000006
• Device Lot Number: 47497456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1