MAUDE Adverse Event Report: ETHICON, JOHNSON & JOHNSON SURGICAL TECHNOLOGIES / ETHICON ENDO-SURGERY, INC. THE LINX REFLUX MANAGEMENT SYSTEM; LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Linx device seems to be opened posteriorly with dislodgement of the connections between beads.Fda safety report id# (b)(4).

• Brand Name: THE LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING
• Manufacturer (Section D): ETHICON, JOHNSON & JOHNSON SURGICAL TECHNOLOGIES / ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 15121622
• MDR Text Key: 296874468
• Report Number: MW5111159
• Device Sequence Number: 1
• Product Code: QJN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American