FDA Adverse Event
Malfunction
Summary report: N
6099569
MDR report key: 6099569
·
Received November 14, 2016
Report
- Report Number
- 6099569
- Event Type
- Malfunction
- Date Received
- November 14, 2016
- Date of Event
- August 22, 2016
- Report Date
- August 31, 2016
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A LAPAROSCOPY PROCEDURE, WHILE SUTURING WITH A 2-0 VICRYL SH* NEEDLE, THE NEEDLE BROKE OFF TO THREE PIECES. ALL PIECES WERE RETRIEVED AND CONFIRMED TO THE ORIGINAL SHAPE AND LENGTH.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |