MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER HEMOSTAT; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number SU2734

Device Problem Break (1069)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

Tip of hemostat broke off during surgery.Guide pin was being placed into same area and hemostat tip was struck, sheared off, retrieved.Was not left in patient's knee.No harm to patient.X-ray taken and confirmed no pieces or parts of hemostat was left inside the patient's knee.

• Brand Name: V. MUELLER HEMOSTAT
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION 2200, INC.
• MDR Report Key: 16895052
• MDR Text Key: 314947235
• Report Number: MW5117383
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2023

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 Model Number: SU2734
• Device Catalogue Number: SU2734
• Device Lot Number: L17XMRCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White