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

Model Number	13
Health Effect - Clinical Codes	Perforation (2001); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was in for colonoscopy with endoscopic ultrasound and possible full thickness resection device (ftrd).Lesion found and assessed by doctors.They felt it needed to be removed via ftrd.After performing clip placement and snaring of lesion it was quickly noted that there was a sigmoid colon perforation.The scrub tech looked at the ftrd system that was removed from the scope and saw that the ovesco clip did not deploy.So, the clip did not grab the tissue prior to snaring and cutting the lesion.Doctor (who had performed ftrd) then decided to stitch with x-tack sutures.Patient's belly became severely distended and veress needle had to be placed into the abdomen by doctor.Doctor was able to suture the perforation, however, patient had to be admitted.Ftrd was attempting to be used to close a large defect/hole in the mucosa after a polypectomy.For some reason clip that closed the gap did not attach to patient and the defect/hole was closed with suture instead.Device retained and placed in red bin.Staff unable to tell if was device, user or anatomy.

• Brand Name: DIAGNOSTIC FTRD SET
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; 120 quade drive; cary NC 27513
• MDR Report Key: 12786495
• Report Number: 12786495
• Device Sequence Number: 14473396
• Product Code: OCZ
• UDI-Device Identifier: 04260206311072
• UDI-Public: (01)04260206311072(17)230430(10)826006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2021
• Report Date (Section F): 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 13
• Device Catalogue Number: 200.76
• Device Lot Number: 826006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 67 KG
• Date Report Sent to FDA: 10/10/2021