FDA Adverse Event
Injury
Summary report: N
DISPOSABLE PURSTRING 65 INSTRUMENT
MDR report key: 1000206
·
Received February 19, 2008
Report
- Report Number
- 2647580-2008-00081
- Event Type
- Injury
- Date Received
- February 19, 2008
- Date of Event
- January 17, 2008
- Report Date
- January 21, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GAG
- PMA / PMN Number
- K901107
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 02/19/2008.
Description of Event or Problem · 1
PATIENT SEX: UNK. PROCEDURE TYPE: LAR- DOUBLE STAPLE. ACCORDING TO THE REPORTER: THE DEVICE WAS APPLIED TO THE PROXIMAL COLON. HOWEVER, ABOUT ONE-THIRD TO HALF OF THE TISSUE WAS CLOSED COMPLETELY. THE INCOMPLETE PURSTRING WAS REMOVED BY CUTTING PATIENT SIDE AND ANOTHER DEVICE WAS USED TO RE-FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE PURSTRING 65 INSTRUMENT | DISPOSABLE SURGICAL STAPLER | GAG | PONCE - USS | P7G0750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |