MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; LAP BASIC GENERAL SURGERY

Model Number	DYNJ68770
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, lap sponge in a sterile custom pack is discovered dirty after the procedure.Email received by patricia delgrosso, mountainside medical center, who provided additional information in regards to this reported incident.Reporter states, it was not until the lap sponges were being opened up on the back table and separated prior to being used on the patient when the brown spot on the sponge was discovered.However, the discovery was at the end of the robotic hernia repair procedure.Reporter states, patient was given additional antibiotics post-operatively.Sample is available for return and evaluation.Results of qa investigation: "due to the staining being within the fibers of the lap sponge the root cause is considered to be a vendor product issue relating to the component manufacturing process." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported, lap sponge in a sterile custom pack is discovered dirty after the procedure.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: LAP BASIC GENERAL SURGERY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12333486
• Report Number: 1423395-2021-00039
• Device Sequence Number: 3974225
• Product Code: FDE
• UDI-Device Identifier: 10193489837919
• UDI-Public: 10193489837919
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DYNJ68770
• Device Catalogue Number: DYNJ68770
• Device Lot Number: 21CBE043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention