MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PENCIL, CAUTERY, PUSH BUTTON, PTFE

Catalog Number	ESPB3002P
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are having an issue with our bovie pencils cutting.The nurses are having to turn up the bovie machines very high to get the pencils to work.".
Additional Manufacturer Narrative
The account reported finding defective bovie pencils, and according to the customer, the item typically operates effectively at 50¿60 watts during electrosurgery; however, in this instance, it reportedly required an increase to 90 watts to function properly.One (1) unit was received in its original packaging for testing; visual inspection was performed, no defects or abnormalities were observed, production records did not find any nonconformances, and functional inspection was conducted.The complaint cannot be confirmed, as the item functions properly and meets all required specifications.The updated cause code has been adjusted to dc: traced to user with preference/item to spec, and no quality defects or abnormalities were identified in the tested sample.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: PENCIL, CAUTERY, PUSH BUTTON, PTFE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50667811
• Report Number: 1417592-2026-33572
• Device Sequence Number: 10235191
• Product Code: GEI
• UDI-Device Identifier: 10193489017724
• UDI-Public: 10193489017724
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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
• Device Catalogue Number: ESPB3002P
• Device Lot Number: 09525020006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown