FDA Adverse Event
Injury
Summary report: N
SURGICLIP
MDR report key: 2315328
·
Received October 18, 2011
Report
- Report Number
- 2315328
- Event Type
- Injury
- Date Received
- October 18, 2011
- Date of Event
- August 2, 2011
- Report Date
- October 18, 2011
- Manufacturer
- COVIDIEN
- Product Code
- GDO
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
COVIDIEN AUTOSUTURE PREMIUM SURGICLIP S-9.0, REF #134046 WAS BEING USED BY SURGEON. PER SURGEON, THE SURGICLIP DAMAGED THE PATIENT'S LEFT INTERNAL MAMMARY ARTERY (LIMA) DURING OPEN HEART PROCEDURE. CLIP AND APPLIER SENT TO BIOMED.
Description of Event or Problem · 1
COVIDIEN AUTOSUTURE PREMIUM SURGICLIP S-9.0, (B)(4) WAS BEING USED BY SURGEON. PER SURGEON, THE SURGICLIP DAMAGED THE PATIENT'S LEFT INTERNAL MAMMARY ARTERY (LIMA) DURING OPEN HEART PROCEDURE. CLIP AND APPLIER SENT TO BIOMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICLIP | CLIP APPLIER | GDO | COVIDIEN | 134046 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |