FDA Adverse Event
Other
Summary report: N
INSORB SUBCUTICULAR STAPLER
MDR report key: 3329747
·
Received August 30, 2013
Report
- Report Number
- 3004028675-2013-00016
- Event Type
- Other
- Date Received
- August 30, 2013
- Date of Event
- July 10, 2013
- Report Date
- July 12, 2013
- Manufacturer
- INCISIVE SURGICAL, INC.
- Product Code
- GDT
- PMA / PMN Number
- K120373
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MFR.
Description of Event or Problem · 1
A PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURE AND THE INSORB 2030 SKIN STAPLER WAS USED TO CLOSE THE SKIN INCISION. THE PATIENT EXPERIENCED A WOUND SEPARATION AT 4 DAYS POST OP. WHICH WAS CLOSED IN THE OPERATING ROOM WITH SUTURE UNDER GENERAL ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431055 | INSORB SUBCUTICULAR STAPLER | SKIN STAPLER | GDT | INCISIVE SURGICAL, INC. | 2030 | 130301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |