FDA Adverse Event
Injury
Summary report: N
GIA 80-3.8 SINGLE USE LOADING UNIT
MDR report key: 3964912
·
Received July 19, 2014
Report
- Report Number
- 2647580-2014-00442
- Event Type
- Injury
- Date Received
- July 19, 2014
- Date of Event
- May 20, 2014
- Report Date
- May 30, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
- Product Code
- GDW
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: DURING THIS SURGICAL INTERVENTION IT WAS NOTED THAT MOMENTS AFTER THE FIRST SHOT THE STAPLE LINE PRESENTED DEFICIENT HEMOSTASIS. MOMENTS AFTER IT STARTED BLEEDING. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE STAPLE LINE WAS REINFORCED WITH MANUAL SUTURE. THE PT HAD TO BE RE-OPERATED ON TWICE DUE TO MICRO DEHISCENCE ON SIDE LATERAL ANASTOMOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 424095 | GIA 80-3.8 SINGLE USE LOADING UNIT | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO, INC. | P4A0488X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | GIA8038S LOT #: P3L0236KX EXP: 11/30/2018| GIA 80-3.8 SINGLE USE RELOADABLE MFG: 11/2013 |