MAUDE Adverse Event Report: OVESCO ENDOSCOPY AG DIAGNOSTIC FTRD SET; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 200.76

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Failed to deploy, removed endoscope with device.

• Brand Name: DIAGNOSTIC FTRD SET
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; 15300 weston parkway; suite 101; cary NC 27513
• MDR Report Key: 16050944
• MDR Text Key: 306171521
• Report Number: 16050944
• Device Sequence Number: 1
• Product Code: OCZ
• 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: 12/02/2022

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: Other
• Device Model Number: 200.76
• Device Catalogue Number: 200.76
• Device Lot Number: 834867
• 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: 12/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA