MAUDE Adverse Event Report: GYRUS ACMI, INC. GRASPING FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number E8215

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

Physician in process of removing stent placed in patient on (b)(6) 2023 ,when grasper broke while in patient.Small metal piece retrieved.

• Brand Name: GRASPING FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant; st. norwalk OH 44857
• MDR Report Key: 17565944
• MDR Text Key: 321523583
• Report Number: MW5144679
• 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
• Type of Report: Initial
• Report Date: 08/14/2023

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: E8215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female