FDA Adverse Event
Injury
Summary report: N
EGIA 60 ARTICULATING MED/THICK SULU
MDR report key: 2221305
·
Received August 17, 2011
Report
- Report Number
- 1219930-2011-00697
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 27, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC RIGHT HEMICOLECTOMY. ACCORDING TO THE REPORTER: AFTER THE ANASTOMOSIS, THE BLIND END OF COLON WAS RESECTED BY THE DEVICE. AFTER THE JAWS WERE RELEASED, THE TISSUE REMAINED IN THE STAPLE POCKET. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM. OOZING OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGIA 60 ARTICULATING MED/THICK SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N1F0585ULX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |