FDA Adverse Event
Injury
Summary report: N
EEA 33MM SINGLE-USE STAPLER
MDR report key: 1163127
·
Received September 16, 2008
Report
- Report Number
- 1219930-2008-00688
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 15, 2008
- Report Date
- September 2, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPROT SENT: 09/16/2008
Description of Event or Problem · 1
PROCEDURE TYPE: LEFT HEMICOLECTOMY. ACCORDING TO THE REPORTER: INSTRUMENT FIRED PARTIALLY DURING LEFT HEMICOLECTOMY ANASTOMOSIS. ALSO IT PRODUCED NO TACTILE FEEDBACK. THE AREA THAT STAPLES DID NOT FORM WAS SUTURED OVER. SURGERY TIME WAS EXTENDED ONE HOUR DUE TO THE DIFFICULT ACCESS FOR SUTURING. THERE WAS NO TISSUE DAMAGE, NO STOMA, AND NO BLEEDING REPORTED. PATIENT IS CURRENTLY IN WELL CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 33MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U7H91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |