FDA Adverse Event
Injury
Summary report: N
GIA 100-3.8 SINGLE USE RELOADABLE STAPLE
MDR report key: 954737
·
Received November 27, 2007
Report
- Report Number
- 1219930-2007-00737
- Event Type
- Injury
- Date Received
- November 27, 2007
- Date of Event
- October 18, 2007
- Report Date
- October 22, 2007
- Manufacturer
- NORTH HAVEN-USS
- Product Code
- GAG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 11/16/2007.
Description of Event or Problem · 1
PT SEX: UNK. PROCEDURE TYPE: J-POUCH/LARGE BOWEL RESECTION. ACCORDING TO THE REPORTER: AT THE 2ND FIRING, THE KNIFE STOPPED, AND THE BOWEL TORE. MANUAL SUTURING WAS ADDED TO REPAIR THE BOWEL AND THE PROCEDURE WAS COMPLETED. THE SURGERY WAS EXTENDED ABOUT 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA 100-3.8 SINGLE USE RELOADABLE STAPLE | NONE | GAG | NORTH HAVEN-USS | U6A110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R |