FDA Adverse Event
Malfunction
Summary report: N
OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM
MDR report key: 19139659
·
Received April 18, 2024
Report
- Report Number
- 3005099803-2024-01840
- Event Type
- Malfunction
- Date Received
- April 18, 2024
- Date of Event
- April 8, 2024
- Report Date
- April 18, 2024
- Manufacturer
- VIANT MEDICAL INC
- Product Code
- OCW
- UDI-DI
- 20811955020715
- PMA / PMN Number
- K210266
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 8, 2024 THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM DEVICE DEFECT DURING ASSEMBLY. ON (B)(6) 2024, THE PHYSICIAN REPORT THAT THE ANTERIOR BAND ON THE OVERSTITCH WAS BROKEN. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS CANCELLED/RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2587228 | OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM | ENDOSCOPIC TISSUE APPROXIMATION DEVICE | OCW | VIANT MEDICAL INC | ESS-G02-SX1 | 2023040002 | 20811955020715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |