MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-15 for OVERSTITCH ENDOSCOPIC SUTURING SYSTEM ESS-G02-160 manufactured by Apollo Endosurgery, Inc..
[181232974]
The reporter of the event was asked to return the product for analysis. To date, the device has not been received by apollo. Device labeling addresses the reported event as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures. Ensure that there is sufficient space for the needle to open. Warning: do not introduce the device with the needle body in its open position. Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: abdominal pain and / or bloating. Pharyngeal, colonic and/or esophageal perforation. Esophageal, colonic and/or pharyngeal laceration. Intra-abdominal (hollow or solid) visceral injury.
Patient Sequence No: 1, Text Type: N, H10
[181232975]
Reported as: "other aes were graded as mild (24 out of 342 cases; 7. 0%). These included submucosal esophageal tear requiring clipping or suturing (5), superficial mucosal esophageal abrasion not requiring an intervention (5), oozing from a suture site that stopped spontaneously (4), bleeding at a suture site requiring either epinephrine injection or early cinching to tamponade (3), suture breakage (1), abdominal pain (3), nausea (1), non-cardiac chest pain (1) and severe constipation (1). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00008 |
| MDR Report Key | 9592468 |
| Report Source | LITERATURE |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. DAVID HOOPER |
| Manufacturer Street | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal | 78746 |
| Manufacturer G1 | VIANT MEDICAL |
| Manufacturer Street | 5079 33RD STREET SE |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVERSTITCH ENDOSCOPIC SUTURING SYSTEM |
| Generic Name | SUTURING SYSTEM |
| Product Code | OCW |
| Date Received | 2020-01-15 |
| Model Number | ESS-G02-160 |
| Catalog Number | ESS-G02-160 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-15 |