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

Catalog Number DYNJ46542M

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

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 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.

• Type of Device: LIVER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 12548139
• MDR Text Key: 274938546
• Report Number: 1423395-2021-00044
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10193489337402
• UDI-Public: 10193489337402
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ46542M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention