FDA Adverse Event
Other
Summary report: N
INSORB SUBCUTICULAR STAPLER
MDR report key: 3027636
·
Received March 21, 2013
Report
- Report Number
- 3004028675-2013-00007
- Event Type
- Other
- Date Received
- March 21, 2013
- Date of Event
- October 19, 2012
- Report Date
- February 22, 2013
- Manufacturer
- INCISIVE SURGICAL, INC.
- Product Code
- GDW
- PMA / PMN Number
- K120373
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
A PATIENT UNDERWENT A ROBOTIC CYSTECTOMY OPERATION AND THE INSORB 2030 SKIN STAPLER WAS USED TO CLOSE THE SKIN INCISIONS FOR ALL PORTS. APPROXIMATELY HALF OF THE 6 CM CAMERA PORT CLOSURE SEPARATED THE SAME DAY. THE SEPARATION WAS CLOSED WITH METAL SKIN STAPLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117467 | INSORB SUBCUTICULAR STAPLER | SKIN STAPLER | GDW | INCISIVE SURGICAL, INC. | 2030 | 121601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |