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

Catalog Number	CDS980383O
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "some of them have had the insulated (white/clear plastic part over blade) come off when gently running a raytec or fingers over it to clean.".
Additional Manufacturer Narrative
The customer reported that the insulated bovie blades in the packs had the insulated, white/clear plastic part over the blade come off when gently running a raytec or fingers over it to clean.Medline's investigation reviewed finished good production records and finished good pack build, and no sample or photo was received for investigation.The defect could not be confirmed because no samples or detailed pictures were received, and without a sample it is difficult to determine a true root cause.The complaint was provided to the vendor for further evaluation, and the vendor was unable to determine a root cause; no corrective actions were established at this time, and supplier quality will monitor this issue for trending purposes.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-UROLOGY MAJOR CDS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896948
• Report Number: 1417592-2026-50780
• Device Sequence Number: 5829397
• Product Code: OJH
• UDI-Device Identifier: 40195327251193
• UDI-Public: 40195327251193
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/24/2026

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: CDS980383O
• Was Device Available for Evaluation?: No
• 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: 03/07/2024
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown