MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; OR TURNOVER KIT

Model Number DYKC1586

Device Problems Device Slipped (1584); Device Contamination with Chemical or Other Material (2944)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was undergoing a scheduled davinci bilateral inguinal hernia repair that was converted to a laparoscopic hernia repair when a problem was encountered during the second half of the procedure.The facility reported the following incident: the charge nurse and the facility associate were urgently called to the operating room.Upon arrival the nurse and anesthesiologist were trying to reposition the patient on the regular operating room table.According to the scrub technician and the surgeon, they noticed that one of the davinci arms alarmed indicating the instrument has been removed.The same staff noticed that the arm was outside of the patient's abdomen and was missing a loaded needle at the end of it.Attention was quickly directed to the patient's position on the bed.The patient was found shifted off of the bed about 2 inches causing the davinci arm to exit one of the abdominal incisions.The sterile field and robot arms were contaminated during repositioning so new supplies were called in.The surgeon converted the procedure from a robotic to a laparoscopic approach.A needle was left inside of the patient from the loss of the initial positioning; however the needle was successfully removed after the procedure was restarted laparoscopically.The actual sample is not available to return for evaluation.Due to the reported incident and 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 Description

It was reported that the patient was undergoing a scheduled davinci bilateral inguinal hernia repair that was converted from a robotic to a laparoscopic hernia repair when the patient was found shifted off of the bed about 2 inches causing the davinci arm to exit one of the abdominal incisions and the sterile field was contaminated.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: OR TURNOVER KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11603096
• MDR Text Key: 243417738
• Report Number: 1417592-2021-00064
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10193489472837
• UDI-Public: 10193489472837
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYKC1586
• Device Catalogue Number: DYKC1586
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• 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
• Patient Age: 59 YR
• Patient Weight: 101