FDA Adverse Event
Malfunction
Summary report: N
ENDO GIA
MDR report key: 7336188
·
Received March 13, 2018
Report
- Report Number
- 1219930-2018-01470
- Event Type
- Malfunction
- Date Received
- March 13, 2018
- Date of Event
- February 23, 2018
- Report Date
- April 11, 2018
- Manufacturer
- COVIDIEN LP LLC NORTH HAVEN
- Product Code
- GDW
- PMA / PMN Number
- K102291
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE ISSUE OCCURRED DURING LOBECTOMY WHEREIN THE SURGEON WAS ORIGINALLY USING A COMPETITOR'S DEVICE BUT IT DIDN'T WORKED AS EXPECTED SO IT WAS REPLACED BY A NEW HANDLE AND A RELOAD. UPON FIRING, A CRACKING SOUND WAS HEARD AND THE HANDLE BECAME IDLE. THE FIRING WAS STOPPED HALFWAY. AFTER THAT INCIDENT, PLASTIC PIECES OF CREAM COLOR WERE FOUND FROM INTERSPACE OF THE GREEN FIRING BUTTON, WHICH WERE RETRIEVED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177584 | ENDO GIA | STAPLE, IMPLANTABLE | GDW | COVIDIEN LP LLC NORTH HAVEN | EGIARADXT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |