MAUDE Adverse Event Report: STERIS /UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR TOOL; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 00711177

Device Problem Difficult to Open or Close (2921)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 4:42 pm by risk, rde - raptor tool used for foreign body removal.Device worked on first pass, but during the second pass gi tech was unable to open raptor.

• Brand Name: RAPTOR TOOL
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STERIS /UNITED STATES ENDOSCOPY GROUP, INC.
• MDR Report Key: 16573824
• MDR Text Key: 311692639
• Report Number: MW5115832
• Device Sequence Number: 1
• Product Code: OCZ
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00711177
• Device Lot Number: 442392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White