FDA Adverse Event
Injury
Summary report: N
GIA100-3.8 SINGLE USE RELOADABLE STAPLER
MDR report key: 1024775
·
Received April 2, 2008
Report
- Report Number
- 2647580-2008-00194
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 7, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GAG
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 04/02/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED AND STAPLES DID NOT FORM. TISSUE DAMAGE WAS OBSERVED. THE DOCTOR REMOVED THE DAMAGED TISSUE WHEN A SECOND DEVICE WAS FIRED AND THE CASE WAS THEN COMPLETED WITHOUT ANY FURTHER ISSUES. NO FURTHER INFO COULD BE OBTAINED ABOUT THE PT OR PROCEDURE DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA100-3.8 SINGLE USE RELOADABLE STAPLER | DISPOSABLE SURGICAL STAPLER | GAG | PONCE - USS | P7F0378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | PRODUCT ID# GIA10038L| GIA 100-3.8 SINGLE USE LOADING UNIT| LOT #: P7F0710 |