FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH
MDR report key: 11504333
·
Received March 17, 2021
Report
- Report Number
- 11504333
- Event Type
- Malfunction
- Date Received
- March 17, 2021
- Date of Event
- February 11, 2021
- Report Date
- March 9, 2021
- Manufacturer
- COVIDIEN LP
- Product Code
- OCW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 0
COVIDIEN LP ENDO STITCH ENDOSCOPIC SUTURING UNIT WAS BEING USED TO SUTURE DURING SURGERY. THE V-LOC NEEDLE THAT WAS BEING USED BROKE AND PART OF THE NEEDLE BECAME LODGED IN THE ENDO STITCH UNIT. A NEW ENDO STITCH ENDOSCOPIC SUTURING UNIT AND V-LOC WERE OPENED AND USED DURING THE SURGICAL PROCEDURE.
Description of Event or Problem · 1
COVIDIEN LP ENDO STITCH ENDOSCOPIC SUTURING UNIT WAS BEING USED TO SUTURE DURING SURGERY. THE V-LOC NEEDLE THAT WAS BEING USED BROKE AND PART OF THE NEEDLE BECAME LODGED IN THE ENDO STITCH UNIT. A NEW ENDO STITCH ENDOSCOPIC SUTURING UNIT AND V-LOC WERE OPENED AND USED DURING THE SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402569 | ENDO STITCH | ENDOSCOPIC TISSUE APPROXIMATION DEVICE | OCW | COVIDIEN LP | 173016 | J9M1107EY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16060 DA |