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

Model Number 13

Device Problem Activation Failure (3270)

Patient Problems Perforation (2001); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2021

Event Type  Injury  

Event 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
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): OVESCO ENDOSCOPY AG; 120 quade drive; cary NC 27513
• MDR Report Key: 12786495
• MDR Text Key: 280579020
• Report Number: 12786495
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04260206311072
• UDI-Public: (01)04260206311072(17)230430(10)826006
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2021,10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 10/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 27740 DA
• Patient Sex: Male
• Patient Weight: 67 KG