MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CAUTERY CORD, BIPOLAR, STRL

Catalog Number	DYNJ01207
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the bipolar ceased to work.When it was investigated, the rn found that the cable was not maintaining connection with the contacts inside the machine.
Additional Manufacturer Narrative
The customer reported that the bipolar ceased to work during surgery, the rn found that the cable was not maintaining connection with the contacts inside the machine, and the metal contacts appear to have been crimped or crushed; no injury was reported.A sample was received without its original packaging, visual inspection observed that the cords were bent with no additional visible damage, finished good production records and finished good pack build were reviewed, and component trending was reviewed.Based on the complaint details, sample evaluation, and investigation, the complaint has been confirmed; visual inspection revealed that the prongs were bent and did not meet the expected specifications, and no functional inspection could be conducted due to the observed defect.No information was available regarding the storage conditions or usage history of the item, so the root cause of this issue cannot be determined at this time; the division 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: CAUTERY CORD, BIPOLAR, STRL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50753161
• Report Number: 1417592-2026-39043
• Device Sequence Number: 13178647
• Product Code: GEI
• UDI-Device Identifier: 10080196800612
• UDI-Public: 10080196800612
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K932654
• 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): 09/10/2026

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: DYNJ01207
• Device Lot Number: 25KBT784
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2026
• 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: 03/10/2026
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown