FDA Adverse Event
Malfunction
Summary report: N
ENDO GIA ULTRA
MDR report key: 8113715
·
Received November 28, 2018
Report
- Report Number
- 2647580-2018-05804
- Event Type
- Malfunction
- Date Received
- November 28, 2018
- Date of Event
- November 5, 2018
- Report Date
- January 3, 2019
- Manufacturer
- US SURGICAL PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K111825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: (MODEL #, CATALOG #, UDI #), (5/10 K #).IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER TUMOR RESECTION PROCEDURE, THE HANDLE COULD NOT BE SQUEEZED AND THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 953171 | ENDO GIA ULTRA | STAPLE, IMPLANTABLE | GDW | US SURGICAL PUERTO RICO | EGIAUSTND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |