MAUDE Adverse Event Report: AESCULAP AG VARADY VARIX EXTRACTOR W/HOOK180MM; GENERAL INSTR.CARDIOVASC.& THO

Model Number FB121R

Device Problem Material Fragmentation (1261)

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

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with fb121r - varady varix extractor w/hook180mm.According to the complaint description, during a varicose vein operation, the tip of the phlebotomy is broken off without much force and disappears into the adipose tissue.Only after a longer period of time with x-ray and extension of the incision could the broken tip be recovered.Additional medical intervention was necessary - x-ray.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference 400487838.

Manufacturer Narrative

Investigation results: vigilance investigator carried out the pictorial documentation visually and microscopically.The remaining end of the fractured working end is bent, most likely by an overload situation during handling.At the fracture pattern, dark and light areas with different structures can be found.Probably, pre-cracks occurred during former applications and in the end, a forced fracture caused the fracture of the working end.Ats stamp can be found at the instrument "ats0705", therefore the instrument was last serviced in may 2007.

• Brand Name: VARADY VARIX EXTRACTOR W/HOOK180MM
• Type of Device: GENERAL INSTR.CARDIOVASC.& THO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10729356
• MDR Text Key: 212962043
• Report Number: 9610612-2020-00757
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: A883579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB121R
• Device Catalogue Number: FB121R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention