MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; EMH LAPAROSCOPY PACK

Catalog Number	DYNJ63350F
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the raytec in a pack broke/shred in half during a patient's surgery in the (b)(6) operating room.Sponge was held up against another sponge to ensure all pieces were accounted for.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.
Event or Problem Description
The raytec in a pack broke/shred in half during a patient's surgery in the (b)(6) operating room.

• Brand Name: MEDLINE
• Common Device Name: EMH LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; baja california 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25512478
• Report Number: 1423395-2026-00210
• Device Sequence Number: 10589241
• Product Code: FDE
• UDI-Device Identifier: 10198459120015
• UDI-Public: 10198459120015
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: DYNJ63350F
• Device Lot Number: 26BMG477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2028
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown