FDA Adverse Event
Injury
Summary report: N
UNK ENDO STITCH INSTRUMENT
MDR report key: 1030737
·
Received April 17, 2008
Report
- Report Number
- 1219930-2008-00302
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 24, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- MFJ
- PMA / PMN Number
- K934738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC HYSTERECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE DOCTOR NOTED THAT ONE HALF OF THE ENDO STITCH NEEDLE WAS MISSING WHILE LOOKING THROUGH THE SCOPE AND WORKING WITH THE DEVICE. THE PERITONEUM WAS INSPECTED FOR MISSING HALF WITH OUT SUCCESS. AN X-RAY WAS TAKEN IN THE PACU AND THE NEEDLE WAS VISUALIZED. THE PT WAS RETURNED TO THE OR TO HAVE THE NEEDLE REMOVED. THIS DEVICE FAILURE DID NOT PROLONG PT'S NORMAL STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK ENDO STITCH INSTRUMENT | DISPOSABLE SUTURING DEVICE | MFJ | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |