MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROBOTIC GENERAL / THORACIC

Catalog Number	DYNJ0774133P
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, when the surgeon was removing the "raytec from the cavity through the trocar" the chip fell "into the patient".The customer reported the chip was removed from the patient and the procedure was able to be completed without complications.The customer reported there was no serious injury, medical intervention, or follow-up care provided related to the reported incident.Sample requested for return evaluation.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.
Event or Problem Description
According to the customer, when the surgeon was removing the "raytec from the cavity through the trocar" the chip fell "into the patient".

• Common Device Name: ROBOTIC GENERAL / THORACIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17906266
• Report Number: 1423395-2023-00057
• Device Sequence Number: 7645241
• Product Code: LRO
• UDI-Device Identifier: 10195327416126
• UDI-Public: 10195327416126
• 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): 10/10/2023

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: DYNJ0774133P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown