MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. PHLEBECTOMY HOOK - ANGLED LEFT, 4 1/4" / 11 CM; INSTRUMENT, MICROSURGICAL

Model Number 8008-232

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

During phlebectomy procedure, a phlebectomy hook tip seemed to have broken off.Unsure if it is in the patient or on the floor or in the drapes.Multiple x-rays were taken of the patient's entire leg which did not display the tip.

• Brand Name: PHLEBECTOMY HOOK - ANGLED LEFT, 4 1/4" / 11 CM
• Type of Device: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; 1 scanlan plaza; saint paul MN 55107
• MDR Report Key: 15492235
• MDR Text Key: 300642836
• Report Number: 15492235
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8008-232
• Device Catalogue Number: 8008-232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Female
• Patient Weight: 141 KG