MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L E.S. PENCIL,PUSHBUTTON, WITH HOLSTER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-000002
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "coagulator button and cut button worked incorrectly, the buttons did the opposite of what was labeled." deroyal industries has requested return of the sample but it has been received yet.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "coagulator button and cut button worked incorrectly, the buttons did the opposite of what was labeled.".
Additional Manufacturer Narrative
A user facility reported, "coagulator button and cut button worked incorrectly, the buttons did the opposite of what was labeled." deroyal industries has requested return of the sample and received it on 5/15/2024.Deroyal industries reviewed the device history record and found no issues.Functional results from the lot of the affected product were reviewed and no issues were found with the continuity test.The failure modes and effects analysis (fmea) and well as material review reports (mrrs) were reviewed and found that no updates or issues were found.The returned samples was inspected and confirmed that the coagulator and cut buttons were working incorrectly.Upon disassembly of the device, it was noticed that two of the three terminals of the cable were not soldered in the correct position causing the issue within the cautery pencil.Inventory was also inspected.There was no inventory with the affected lot, however the same product number from a different lot was found.Fifty samples were tested and no issues were identified.A complaint to sales ratio was conducted over the last two years and found to be 0.0097%.Root cause: a manufacturing error of the soldering of two cables in the incorrect positions.This was not able to be observed in the 100% inspection and as a conclusion the root cause was determined to be lack of adherence to the manufacturing specifications.Corrective and preventive actions: operators involved received a retraining on the manufacturing procedure.Work orders produced after the retraining were reviewed and confirmed to be correct showing retraining was effective.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: E.S. PENCIL,PUSHBUTTON, WITH HOLSTER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19954378
• Report Number: 9613793-2024-00001
• Device Sequence Number: 18345555
• Product Code: GEI
• UDI-Device Identifier: 00749756053280
• UDI-Public: 00749756053280
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K940909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 88-000002
• Device Lot Number: 55217291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown