MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for OVERSTITCH ENDOSCOPIC SUTURING SYSTEM ESS-G02-160 manufactured by Apollo Endosurgery, Inc..
[125781187]
Output procedure planned for esophagogastroduodenoscopy (egd) with stent insertion with fixation using apollo overstitch. First suture was able to grasp the stent; when attempting to grab the tissue of the esophagus the needle would not grasp onto the apparatus. Rn and doctor noticed at that time that the needle was bent. Therefore that suture had to be anchored and cut and a new suturing system was applied. Doctor inserted scope with the apparatus and again was able to grasp the stent with the suture but upon grasping the tissue of the esophagus, the rn and doctor noticed that the needle was bent again. The doctor went in and cut the suture with the endo-loop cutter and was not able to suture the esophageal stent to the esophagus due to equipment malfunction twice. Equipment was sent in red bag to be reprocessed to be evaluated by company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8027388 |
| MDR Report Key | 8027388 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-23 |
| Report Date | 2018-10-25 |
| Date Reported to FDA | 2018-10-25 |
| Date Reported to Mfgr | 2018-11-01 |
| Date Added to Maude | 2018-11-01 |
| 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 | OVERSTITCH ENDOSCOPIC SUTURING SYSTEM |
| Generic Name | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Product Code | HCF |
| Date Received | 2018-11-01 |
| Model Number | ESS-G02-160 |
| Catalog Number | ESS-G02-160 |
| Lot Number | 2018031262 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S CAPITAL OF TX HWY BLDG 1, STE 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-01 |