MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LIVER PACK

Catalog Number	DYNJ46542M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The yellow suture boot split and fell off of the device into the patient's abdomen requiring the surgeon to manually remove the suture boot from the surgical site during the procedure.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.There was no report of any adverse patient consequence, no effect on the patient's stability, and no additional intervention required as a result of the incident.A photo was received for evaluation which observed the suture boot that is placed on the instrument is cracked starting at the top and continuing to split down the side of the suture boot almost to the bottom.It appears that only one of the two suture boots on the instrument was cracked and the crack is occurring on the interior side of the instrument clamps that close together and meet the other clamp.There does not appear to be any other physical damage to the suture boots.The actual sample was not returned to the manufacturer for evaluation.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
The yellow suture boot split and fell off of the device into the patient's abdomen requiring the surgeon to manually remove the suture boot from the surgical site during the procedure.

• Common Device Name: LIVER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12548139
• Report Number: 1423395-2021-00044
• Device Sequence Number: 16966328
• Product Code: LRO
• UDI-Device Identifier: 10193489337402
• UDI-Public: 10193489337402
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ46542M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 09/29/2021
• 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