MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for OVERSTITCH? ENDOSCOPIC SUTURING SYSTEM (ESS) ESS-G02-160 manufactured by Apollo Endosurgery, Inc..
[183975768]
Initial medwatch sent to the fda. The device will not be returned for analysis, hence, analysis of the device is not possible. A review of the device labeling notes the following: the current overstitch? Endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "other-clinical outcome device related" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures. Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. 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: pharyngeal, colonic and/or esophageal perforation esophageal, colonic and/or pharyngeal laceration intra-abdominal (hollow or solid) visceral injury the labeling is adequate as it addresses the reported complaints. The occurrence of this reported complaint for this product will be reviewed as appropriate in the complaints analysis meeting (cam).
Patient Sequence No: 1, Text Type: N, H10
[183975769]
Reported as: patient presented fever 3. 5 weeks after esg procedure. Patient was diagnosed with liver abscess and was hospitalized and treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00046 |
| MDR Report Key | 9808744 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | VIANT MEDICAL |
| Manufacturer Street | 5079 33RD STREET SE |
| Manufacturer City | GRAND RAPIDS, MI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVERSTITCH? ENDOSCOPIC SUTURING SYSTEM (ESS) |
| Generic Name | SUTURING SYSTEM |
| Product Code | OCW |
| Date Received | 2020-03-09 |
| Model Number | ESS-G02-160 |
| Catalog Number | ESS-G02-160 |
| Lot Number | 2019091049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-09 |