FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-4.8 SULU
MDR report key: 2140307
·
Received June 15, 2011
Report
- Report Number
- 1219930-2011-00502
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 6, 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: THORACO/LOBECTOMY. ACCORDING TO THE REPORTER: LEAKAGE WAS FOUND FROM STUMP OF THE BRONCHIAL TUBE AFTER FIRING. IT WAS FOUND THAT MALFORMED STAPLING HAD CAUSED THE INCIDENT. NO ABNORMAL PHENOMENON WAS SEEN DURING FIRING. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM. ADDITIONAL MANUAL SUTURING WAS DONE. NO UNANTICIPATED BLEEDING 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 | ENDO GIA ROTICULATOR 45-4.8 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CATALOG #: 030449| ENDO GIA UNIVERSAL 12MM SINGLE USE INST.| LOT: UNKNOWN |