MAUDE Adverse Event Report: STERILE SATIN FORCEPS WITH TEETH; FORCEPS, GENERAL & PLASTIC SURGERY

Lot Number 2019092701

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

Event Date 02/04/2024

Event Type  Injury  

Event Description

"we just identified multiple one time use instruments with notable "rust" on them from centurion in the dermatology clinic.These items were pulled from our "temp tracked" supply room on 2/6/24.Item lot, exp, sterile satin iris scissors 2023022890 2/29/2028 2, sterile satin iris scissors 2022011890 12/31/2026 1; sterile webster needle holder 2023080190, 7/31/2028, 3 sterile satin forceps with teeth 2019092701 8/31/2024 1, 02/29/2023 2.Pulled from service immediately and not used on patient." ref reports: mw5151319, mw5151320, mw5151321, mw5151322, mw5151324.

• Brand Name: STERILE SATIN FORCEPS WITH TEETH
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• MDR Report Key: 18684719
• MDR Text Key: 335241025
• Report Number: MW5151323
• Device Sequence Number: 1
• Product Code: GEN
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2019092701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Patient Sequence Number: 1
• Treatment: STERILE SATIN IRIS SCISSORS; STERILE WEBSTER NEEDLE HOLDER
• Patient Outcome(s): Required Intervention