MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS, LLC VARADY VEIN HOOK; STRIPPER, VEIN, REUSABLE

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

The tip of the medium crochet vein hook broke off into the patient on first pass.Staff surgeon immediately aware and looked for piece at the surgical site and on the surgical field using both visual inspection and vascular ultrasound inspection.Surgical team searched the surgical field.Circulator searched the operating room floor visually and with a magnet broom.The tip of the crochet vein hook was not located.Surgeon commented that she would be informing the patient.This is at least the fourth patient that this has happened to and previous patients we were able to find the broken tip.

• Brand Name: VARADY VEIN HOOK
• Type of Device: STRIPPER, VEIN, REUSABLE
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS, LLC; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 10232542
• MDR Text Key: 197563332
• Report Number: 10232542
• Device Sequence Number: 1
• Product Code: GAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA