MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ROBOTIC PACK

Catalog Number	DYNJ87316
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 1/3 at the end of a robotic assisted laparoscopic, umbilical hernia repair with mesh procedure, "the raytech was placed in the abdomen and was being pulled through a robotic trocar at the end of the case and it came apart".The surgeon had continued visualization of the rayteach and trocar.Once both 1/2's were removed, the staff informed or management and the safety coordinator.An x-ray was taken.The facility stated there was no impact to the patient or procedure and that there was no serious injury or medical intervention.The procedure was completed.A sample is not available for evaluation.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
According to the facility on 1/3 at the end of a robotic assisted laparoscopic, umbilical hernia repair with mesh procedure, "the raytech was placed in the abdomen and was being pulled through a robotic trocar at the end of the case and it came apart".

• Common Device Name: ROBOTIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21368840
• Report Number: 1423395-2025-00011
• Device Sequence Number: 8590394
• Product Code: OHD
• UDI-Device Identifier: 10198459026041
• UDI-Public: 10198459026041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/12/2025

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?: No
• Device Catalogue Number: DYNJ87316
• Device Lot Number: 24KME840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 73 KG