MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ABDOMINAL CDS

Catalog Number	CDS860120N
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bovie pencil will automatically turn on the cut setting when not triggered.
Additional Manufacturer Narrative
The account reported finding defective bovie, and the end user reported that the cut function would activate even when the button is not pushed; the issue occurred during an abdominal procedure with patient involvement and no injuries.Medline received one used cautery pencil; the rest of the pack, cautery holster, and blade tip were not received, and there was no visual damage or defects with the cautery pencil, cord, or plug end.The vendor response stated that visual inspection found no notable conditions, functional testing found the pencils did not self-activate and functioned normally when activated in the generator, and the reported condition was not confirmed.The primary analysis found no device problem, the product functioned as intended, and the most likely root cause could not be determined.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: DBD-ABDOMINAL CDS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914247
• Report Number: 1417592-2026-51859
• Device Sequence Number: 5370186
• Product Code: LRO
• UDI-Device Identifier: 40193489383905
• UDI-Public: 40193489383905
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 09/25/2026

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: CDS860120N
• Device Lot Number: 22GBI315
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2023
• 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: 01/11/2023
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (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