FDA Adverse Event
Malfunction
Summary report: N
JUSTRIGHT 5MM STAPLER
MDR report key: 18011414
·
Received October 26, 2023
Report
- Report Number
- 18011414
- Event Type
- Malfunction
- Date Received
- October 26, 2023
- Date of Event
- September 8, 2023
- Report Date
- September 29, 2023
- Manufacturer
- JUSTRIGHT SURGICAL, LLC
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING SURGERY PRODUCT WAS NOTED TO NOT FIRE (STAPLES DID NOT CRIMP) WHILE BEING USED ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2000718 | JUSTRIGHT 5MM STAPLER | STAPLER, SURGICAL | GAG | JUSTRIGHT SURGICAL, LLC | JR-ST25-2.0 | 75HB9277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5475 DA | Female |