MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; LAPAROSCOPY PACK CSM

Catalog Number	DYNJT4945
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, on (b)(6) 2025 as a raytec was pulled out of the abdomen "through an 8mm robotic port with an 8mm airseal cap on the trocar, it broke apart." the customer reported being able to retrieve "a portion of it" and removed the remaining raytec "under direct visualization with the robotic scope" using a 5mm atraumatic laparoscopic grasper.The customer confirmed that all pieces of the raytec were able to be removed from the body cavity.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 as a raytec was pulled out of the abdomen "through an 8mm robotic port with an 8mm airseal cap on the trocar, it broke apart." the customer reported being able to retrieve "a portion of it" and removed the remaining raytec "under direct visualization with the robotic scope" using a 5mm atraumatic laparoscopic grasper.The customer confirmed that all pieces of the raytec were able to be removed from the body cavity.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: LAPAROSCOPY PACK CSM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23918599
• Report Number: 1423395-2025-00213
• Device Sequence Number: 9030005
• Product Code: FDE
• UDI-Device Identifier: 10198459459344
• UDI-Public: 10198459459344
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJT4945
• Device Lot Number: 25HMH004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 85 KG