FDA Adverse Event
Injury
Summary report: N
EEA 28MM SINGLE-USE STAPLER
MDR report key: 2140304
·
Received June 15, 2011
Report
- Report Number
- 2647580-2011-00398
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 1, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: AFTER ANASTOMOSIS, WHEN THE DEVICE WAS REMOVED, THE ANASTOMOSIS PART WAS TORN. IT IS UNKNOWN IF THE DEVICE DAMAGED THE PART OR THE ANASTOMOSIS PART WAS UNCUT. THE ORIGINAL STAPLE LINE WAS RESECTED AND RE-ANASTOMOSIS WAS DONE USING ANOTHER DEVICE. BLEEDING UNDER 200CC OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES. UNANTICIPATED TISSUE LOSS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | USSC PUERTO RICO | P0K1113H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |