FDA Adverse Event
Malfunction
Summary report: N
DURACLIP
MDR report key: 20673890
·
Received November 13, 2024
Report
- Report Number
- 20673890
- Event Type
- Malfunction
- Date Received
- November 13, 2024
- Date of Event
- August 30, 2024
- Report Date
- October 7, 2024
- Manufacturer
- TRANSMED (CHINA) CO., LTD.
- Product Code
- PKL
- UDI-DI
- 16932619740033
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURACLIP DID NOT DEPLOY, AND THE END OF IT CAME OFF AFTER THE DEVICE WAS REMOVED FROM THE SCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2070202 | DURACLIP | HEMOSTATIC METAL CLIP FOR THE GI TRACT | PKL | TRANSMED (CHINA) CO., LTD. | DC0235W | M220301592 | 16932619740033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female |