MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ROBOTIC PACK

Catalog Number	DYNJ51834C
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a raytec sponge appears to have torn intraoperatively without any noticeable resistance or indication at the time.The issue was only identified when the team performed a scan with the rf assure wand, which led to the discovery of a retained fragment in the abdomen.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
It was reported that a raytec sponge appears to have torn intraoperatively without any noticeable resistance or indication at the time.

• Brand Name: MEDLINE
• Common Device Name: ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 1170 s northpoint blvd; waukegan IL 60085 6757
• Manufacturer Contact: nakiya graves ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24930634
• Report Number: 1423395-2026-00097
• Device Sequence Number: 5180961
• Product Code: LRO
• UDI-Device Identifier: 10193489237429
• UDI-Public: 10193489237429
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: DYNJ51834C
• Device Lot Number: 25LBR717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown