FDA Adverse Event
Malfunction
Summary report: N
ENDOGIA
MDR report key: 7444225
·
Received April 19, 2018
Report
- Report Number
- 2647580-2018-01949
- Event Type
- Malfunction
- Date Received
- April 19, 2018
- Date of Event
- April 4, 2018
- Report Date
- May 8, 2018
- Manufacturer
- US SURGICAL PUERTO RICO
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
CORRECTION: (MODEL NUM, CATALOG NUM, EXPIRATION DATE, LOT NUM,UDI), 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 SINGLE HOLE THORACOSCOPIC LEFT UPPER LOBE RESECTION, WHILE BEING APPLIED AT THE "FRACTURES", THE STAPLER WAS ABLE TO FIRE BUT THE STAPLE FORMATION WAS POOR. THEY REPLACED THE STAPLE CARTRIDGE WITH A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288230 | ENDOGIA | STAPLE, IMPLANTABLE | GDW | US SURGICAL PUERTO RICO | 030449 | P7C0017X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |