FDA Adverse Event
Injury
Summary report: N
TACKER 20
MDR report key: 217472
·
Received April 3, 1999
Report
- Report Number
- 2939738-1999-00005
- Event Type
- Injury
- Date Received
- April 3, 1999
- Report Date
- March 4, 1999
- Manufacturer
- GUIDANT CARDIAC & VASCULAR SURGERY GROUP ORIGIN MEDSYSTEMS, INC.
- Product Code
- KOG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A LAPAROSCOPIC PROCEDURE, THE UNIT REPORTEDLY MISFIRED, ONE TACK WILL STICK OUT IMMEDIATELY AFTER ONE IS FIRED. THE LAPAROSCOPIC PROCEDURE HAD TO BE CONVERTED TO AN OPEN PROCEDURE, IN ORDER TO COMPLETE THE PROCEDURE WITHOUT PUTTING THE PATIENT IN DANGER. THE PATIENT SUFFERED NO KNOWN COMPLICATIONS DURING OR AFTER THE LAPAROSCOPIC/OPEN PROCEDURE AND WAS LAST REPORTED TO BE IN SAFE CONDITIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TACKER 20 | TACKER DELIVERY SYSTEM | KOG | GUIDANT CARDIAC & VASCULAR SURGERY GROUP ORIGIN MEDSYSTEMS, INC. | OMS-TTSD | 0804982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |