FDA Adverse Event
Injury
Summary report: N
ENDO GIA MEDIUM/THICK RADIAL RELOAD
MDR report key: 3170187
·
Received June 7, 2013
Report
- Report Number
- 1219930-2013-00438
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 17, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GAG
- PMA / PMN Number
- K102291
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE RELOAD STAPLED, BUT DID NOT CUT ANY OF THE TISSUE. SURGEON USED ANOTHER DEVICE TO CUT BELOW WHERE THE RADIAL RELOAD WAS FIRED. NO BLOOD LOSS OF MORE THAN 500CC, NO DELAY IN SURGICAL TIME, NO REINFORCEMENT MATERIALS USED WITH THE RADIAL RELOAD. NO OTHER MANUFACTURER'S PRODUCT WAS USED WITH THE RADIAL RELOAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253839 | ENDO GIA MEDIUM/THICK RADIAL RELOAD | DISPOSABLE STAPLER | GAG | COVIDIEN, FORMERLY US SUR | N3C0114UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |