FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 2140315
·
Received June 15, 2011
Report
- Report Number
- 1219930-2011-00499
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 7, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- 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
PROCEDURE TYPE: LOWER ANTERIOR RESECTION/DOUBLE STAPLING. ACCORDING TO THE REPORTER: MALFORMED STAPLING OCCURRED. A STAPLE FELL IN THE PATIENT CAVITY. THE FALLEN STAPLE COULD BE RETRIEVED. THE SULU WAS BENT. ANOTHER DEVICE WAS USED. NO UNANTICIPATED BLEEDING OCCURRED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | ENDO GIA ROTICULATOR 60-3.5 SULU| CATALOG #: 030458, LOT: UNKNOWN |