FDA Adverse Event
Malfunction
Summary report: N
OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
MDR report key: 22054839
·
Received May 20, 2025
Report
- Report Number
- 3005099803-2025-02264
- Event Type
- Malfunction
- Date Received
- May 20, 2025
- Date of Event
- April 24, 2025
- Report Date
- May 20, 2025
- Manufacturer
- APOLLO ENDOSURGERY
- Product Code
- OCW
- UDI-DI
- 10811955020893
- PMA / PMN Number
- K231553
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF CODE A150208 CAPTURES THE REPORTABLE EVENT OF NEEDLE SHAFT STUCK.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED IN THE STOMACH IN AND ESG PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN ANCHOR EXCHANGE CHANNEL AND COULD NOT BE ADVANCED FORWARD OR BACKWARD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666578 | OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM | ENDOSCOPIC TISSUE APPROXIMATION DEVICE | OCW | APOLLO ENDOSURGERY | ESS-G02-NXT | 10811955020893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |