MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GENERAL LAPAROSCOPY PACK

Catalog Number	DYNJ67250B
Medical Device Problem Codes	Decoupling (1145); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer having issues with bovie cords, might be monopolar.A cord melted and burned a surgeons hand.".
Additional Manufacturer Narrative
The customer reported having issues with bovie cords, might be monopolar, and according to the customer, on 5/19/2023, "cautery dislodging from the cord" and due to this, a burn occurred.Medline¿s investigation noted no sample or photo received, reviewed complaint history, reviewed finished good production records, and reviewed finished good pack build; there are no issues with the build that likely contributed to the reported issue.Medline was unable to confirm the reported defect as there was no samples or detailed pictures that were received, and without a sample it is difficult to determine a true root cause for the reported issue.The supplier quality team will monitor this issue for trending purposes, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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-GENERAL LAPAROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50236066
• Report Number: 1417592-2026-16737
• Device Sequence Number: 13336338
• Product Code: FDE
• UDI-Device Identifier: 40195327292233
• UDI-Public: 40195327292233
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: DYNJ67250B
• Device Lot Number: UNK PDM
• Was Device Available for Evaluation?: Yes
• 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: 05/19/2023
• Initial Report FDA Received Date: 08/13/2026
• 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