MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for OVERSTITCH ENDOSCOPIC SUTURING SYSTEM manufactured by Apollo Endosurgery, Inc..
[182191269]
Initial medwatch submitted to the fda. 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.
Patient Sequence No: 1, Text Type: N, H10
[182191270]
Reported as: post-esg pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00020 |
| MDR Report Key | 9747061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2019-10-24 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2020-02-24 |
| 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 | APOLLO ENDOSURGERY COSTA RICA, SRL |
| Manufacturer Street | COYOL FREE ZONE BUILDING B 13.3 |
| Manufacturer City | ALAJUELA, CS |
| Manufacturer Country | CS |
| 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 | 2020-02-24 |
| 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; 2. Other | 2020-02-24 |