FDA Adverse Event
Malfunction
Summary report: N
CROSSBOW
MDR report key: 18596579
·
Received January 26, 2024
Report
- Report Number
- MW5150845
- Event Type
- Malfunction
- Date Received
- January 26, 2024
- Date of Event
- January 24, 2024
- Report Date
- January 24, 2024
- Manufacturer
- SUTURE EASE, INC.
- Product Code
- OCW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TIP OF DISPOSABLE CROSSBOW POTENTIALLY BROKE OFF INSIDE PATIENT'S ABDOMEN DURING PROCEDURE. XRAY OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796959 | CROSSBOW | ENDOSCOPIC TISSUE APPROXIMATION DEVICE | OCW | SUTURE EASE, INC. | SE-CB | CB230901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Male |