MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GYN LAPAROSCOPY

Catalog Number	DYNJ905868G
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in drape.
Additional Manufacturer Narrative
The reported complaint event was reviewed and did not involve a death or serious injury.The reported product problem/issue of particulate in pack information received was reviewed according to complaint handling procedures.The information reviewed does not indicate that a death or serious injury would be likely to occur if the product problem/issue were to recur.There is currently no information indicating that further review by the clinical product surveillance team is required based upon the requirements of the procedures.In the event that further information is received during investigation that indicates the event may potentially be a reportable adverse event, this complaint will be forwarded to the clinical product surveillance team for evaluation.

• Brand Name: MEDLINE
• Common Device Name: GYN LAPAROSCOPY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24756099
• Report Number: 1423395-2026-00058
• Device Sequence Number: 18337844
• Product Code: OHD
• UDI-Device Identifier: 10198459394607
• UDI-Public: 10198459394607
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/01/2026

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: DYNJ905868G
• Device Lot Number: (10)25LBR900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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