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

Lot Number 828491

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Granuloma (1876)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The doctor was performing colonoscopy w/ full-thickness resection and intended to use ovesco ftrd device.The prior polypectomy site was noted in ascending colon.At both ends of the scar tissue, granulation nodules were noted.In the middle of the scar tissue, very small polypoid tissue was noted.The site was marked by coag and scope was withdrawn and ftrd device mounted.Then, the scope was reinserted, and the marked site was grabbed with large forceps device into the ftrd channel.Clip could not be released (did not deploy), so procedure was ended.No resection of polyp.The ftrd device was removed from scope and the site was reinspected.

• 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: 16723595
• MDR Text Key: 313122296
• Report Number: 16723595
• 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: 04/05/2023,04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 828491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Female
• Patient Weight: 68 KG