MAUDE Adverse Event Report: MEDLINE RENEWAL ENDOPATH ENDOSCOPIC INSTRUMENT, CURVED SCISSORS W/MONOPOLAR CAUTERY; 5DCS @ENDPH, ENDOSCOPIC INSTRUMENT CURVE

Catalog Number	5DCSR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the insulation at the tip of the device is getting stuck in the 5 mm ports and starting to tear when they use the device.A new device was opened to replace bad product.
Additional Manufacturer Narrative
It was reported that the insulation at the tip of the device is getting stuck in the 5 mm ports and starting to tear when they use the device.A new device was opened to replace bad product.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.

• Brand Name: ENDOPATH ENDOSCOPIC INSTRUMENT, CURVED SCISSORS W/MONOPOLAR CAUTERY
• Common Device Name: 5DCS @ENDPH, ENDOSCOPIC INSTRUMENT CURVE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25644356
• Report Number: 3032391-2026-00052
• Device Sequence Number: 9399267
• Product Code: NUJ
• UDI-Device Identifier: 10888277408746
• UDI-Public: 10888277408746
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5DCSR
• Device Lot Number: 561953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown