FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN STAPLING DEVICE
MDR report key: 11223577
·
Received January 25, 2021
Report
- Report Number
- 1219930-2021-00353
- Event Type
- Malfunction
- Date Received
- January 25, 2021
- Report Date
- January 25, 2021
- Manufacturer
- COVIDIEN LP LLC NORTH HAVEN
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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, INTRA-OPERATIVELY, THE DEVICE ABLE TO BE "FIE" HOWEVER IT STOPPED HALFWAY AND PARTIALLY FIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118343 | UNKNOWN STAPLING DEVICE | STAPLE, IMPLANTABLE | GDW | COVIDIEN LP LLC NORTH HAVEN | UNKNOWN STAPLING DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |