FDA Adverse Event
Malfunction
Summary report: N
45 LEFT DISPOSABLE SUTURE SLIDER WITH NITINOL LOO
MDR report key: 1024223
·
Received March 27, 2008
Report
- Report Number
- 2936485-2008-00017
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 28, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GDF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE COMPLAINT INVESTIGATION.
Description of Event or Problem · 1
DURING A SURGERY PROCEDURE, THE SURGEON NOTED THAT THE TIP OF THE SUTURE SLIDER BROKE OFF. THE SURGEON TRIED TO REMOVE ALL BROKEN PIECES. AS PARTS OF THE TIP STILL REMAIN IN THE PATIENT, A REVISION SURGERY BECAME NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 45 LEFT DISPOSABLE SUTURE SLIDER WITH NITINOL LOO | SUTURE SLIDER | GDF | STRYKER ENDOSCOPY SAN JOSE | 05256AG2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |