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 2020-01-20 for OVERSTITCH? ENDOSCOPIC SUTURING SYSTEM THX-165-028 manufactured by Apollo Endosurgery, Inc..
[183979257]
Initial medwatch submitted to the fda. The reporter of the event was asked to return the product for analysis. To date, apollo has not received the device. 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 "helix-could not be removed from tissue" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures. Troubleshooting: helix stuck in tissue: i. Use a suitable accessory through the primary channel to apply counter traction to the tissue around the helix, and pull the helix free. Ii. Once endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the helix. Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: conversion to laparoscopic or open procedure, intra-abdominal (hollow or solid) visceral injury.
Patient Sequence No: 1, Text Type: N, H10
[183979258]
Reported as: "the device stays stuck in the wall of the patient's stomach. Impossible to remove. Risk of tear. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00007 |
| MDR Report Key | 9606964 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-01-20 |
| 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 | APOLLO ENDOSURGERY COSTA RICA, SRL |
| Manufacturer Street | COYOL FREE ZONE BUILDING B 13.3 |
| Manufacturer City | ALAJUELA, |
| 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 | ENDOSCOPIC SUTURING SYSTEM |
| Product Code | OCW |
| Date Received | 2020-01-20 |
| Model Number | THX-165-028 |
| Catalog Number | THX-165-028 |
| Lot Number | AF02904 |
| 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 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-20 |