FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH* 10MM SUTURING DEVICE
MDR report key: 4193640
·
Received October 22, 2014
Report
- Report Number
- 9612501-2014-00368
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 30, 2014
- Report Date
- September 30, 2014
- Manufacturer
- COVIDIEN
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW UP REPORT SENT TO FDA ON 04/06/2015. INITIAL REPORTER'S LAST NAME UPDATED TO CORRECT SPELLING.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE NEEDLE BROKE DURING THE FIRST STITCH. GOT A NEW DEVICE AND CONTINUED WITH THE PROCEDURE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH.THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES.NO DEVICE FRAGMENT FELL INTO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671463 | ENDO STITCH* 10MM SUTURING DEVICE | SINGLE USER SUTURING DEVICE | KOG | COVIDIEN | 173016 | J4E1921X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |