MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LAP CHOLE-LF

Catalog Number	DYNJ910322
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2024 "during a robotic procedure, the foam portion of the large trocar cleaner came off and was in the abdomen".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 "during a robotic procedure, the foam portion of the large trocar cleaner came off and was in the abdomen".Per the facility "the piece was removed and accounted for in its entirety".Per the facility the "surgeon retrieved the piece with a grasper".Per the facility there was no harm to the patient and the patient is "recovering as expected due to their surgical procedure".The sample is not available for 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.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.

• Common Device Name: LAP CHOLE-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 20063725
• Report Number: 1423395-2024-00461
• Device Sequence Number: 12871810
• Product Code: LRO
• UDI-Device Identifier: 40195327626038
• UDI-Public: 40195327626038
• 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): 08/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ910322
• Device Lot Number: 24EMC325
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/26/2024
• 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 Sex: Unknown