MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for FTRD SYSTEM SET 14 200.70 manufactured by Ovesco Endoscopy Ag.
[124687750]
Patient undergoing endoscopic full thickness cecal polypectomy. His medical history is significant for an appendectomy, four prior attempts to resect the polyp, and a tattoo marking the polyp. Both the gastroenterologist and the technician attended the 8 hour training on the use of this device, and have performed approximately one procedure per month since its introduction to this facility six months ago. The technician was operating the hand wheel and snare. He reported the hand wheel feeling "tight" when he made the initial turn, and it got tighter and tighter. He felt a release and a jump, and saw the white ring go forward and tissue go into the cap. He deployed the clip. Everyone in the room thought the clip deployed, but when the device was pulled back, the clip was still attached. The patient had to undergo laparoscopic resection of the terminal ileum and right hemicolectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7994418 |
| MDR Report Key | 7994418 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-10-08 |
| Report Date | 2018-10-19 |
| Date Reported to FDA | 2018-10-19 |
| Date Reported to Mfgr | 2018-10-23 |
| Date Added to Maude | 2018-10-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FTRD SYSTEM SET |
| Generic Name | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED |
| Product Code | OCZ |
| Date Received | 2018-10-23 |
| Model Number | 14 |
| Catalog Number | 200.70 |
| Lot Number | 804494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OVESCO ENDOSCOPY AG |
| Manufacturer Address | 120 QUADE DRIVE CARY NC 27513 US 27513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-23 |