MAUDE Adverse Event Report: Medline Industries, LP Medline; GYN LAPAROSCOPY PACK

Catalog Number	SYNJ10073D
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: GYN LAPAROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; 1170 s northpoint boulevard; waukegan IL 60085 -675
• Manufacturer Contact: martin posada ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50308360
• Report Number: 1423395-2026-00538
• Device Sequence Number: 9862902
• Product Code: OHD
• UDI-Device Identifier: 10193489864540
• UDI-Public: 10193489864540
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: SYNJ10073D
• Device Lot Number: 26DBG580
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown