MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MAJOR ORTHO PACK-LF

Catalog Number	DYNJ85231C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 08/01/2024 "the surgeon was putting the raytec down the trocar into the abdomen" when the sponge ripped and needed to be removed from inside the patient.Per the facility "the raytec was retrieved from the abdomen in 2 pieces and all accounted for".Per the facility the piece was removed "with the robotic arms through the trocar".Per the facility the user is doing "great," and there was no report of serious injury related to the reported incident.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.
Event or Problem Description
According to the facility on 08/01/2024 "the surgeon was putting the raytec down the trocar into the abdomen" when the sponge ripped and needed to be removed from inside the patient.

• Common Device Name: MAJOR ORTHO PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 20071917
• Report Number: 1423395-2024-00462
• Device Sequence Number: 2998508
• Product Code: LRO
• UDI-Device Identifier: 40198459044343
• UDI-Public: 40198459044343
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: DYNJ85231C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• 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 Age: 31 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG