MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT MEDLINE RULER; GYNECOLOGICAL LAPAROSCOPIC KIT

Catalog Number DYNJ56423K

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

During laparoscopic ventral hernia repair, ruler from kit was used to measure defect.When ruler was removed, a 1mm x 1cm section was not present.Surgeon and staff were unable to locate missing fragment either in the patient or in the operating room.Decision was made to close patient and not perform open procedure.

• Brand Name: MEDLINE RULER
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; northfield IL 60093
• MDR Report Key: 16844472
• MDR Text Key: 314378662
• Report Number: MW5117159
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ56423K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DAVINCI XI PACK-LF
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White