FDA Adverse Event
Malfunction
Summary report: N
ENDO GIA ULTRA
MDR report key: 11912669
·
Received June 1, 2021
Report
- Report Number
- 2647580-2021-01835
- Event Type
- Malfunction
- Date Received
- June 1, 2021
- Date of Event
- May 6, 2021
- Report Date
- June 1, 2021
- Manufacturer
- US SURGICAL PUERTO RICO
- Product Code
- GDW
- UDI-DI
- 10884523003550
- PMA / PMN Number
- K111825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
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, DURING A LAPAROSCOPIC SMALL BOWEL OBSTRUCTION, THE STAPLER WAS ABLE TO FIRE, BUT THE ARTICULATION KNOB BR OKE OFF AND THERE WAS POOR STAPLE FORMATION. HAND SEW WAS PERFORMED TO RESOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808872 | ENDO GIA ULTRA | STAPLE, IMPLANTABLE | GDW | US SURGICAL PUERTO RICO | EGIAUXL | P9F1497Y | 10884523003550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |