FDA Adverse Event
Injury
Summary report: N
VERSAONE BLADED 5MM STD FIX X6
MDR report key: 6200528
·
Received December 22, 2016
Report
- Report Number
- 1219930-2016-01413
- Event Type
- Injury
- Date Received
- December 22, 2016
- Report Date
- November 17, 2016
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GCJ
- PMA / PMN Number
- K151548
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT WAS DETERMINED TO BE A DUPLICATE.REFER TO INITIAL REPORT: 9612501-2016-01059.
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE. (B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE SURGEON COMPLAIN THAT THE DEVICE DID NOT DEFLATE FAST ENOUGH DURING A BRADYCARDIA CONDITION WITH THE PATIENT. A 12MM TROCAR HAD TO BE PLACED IN EMERGENCY TO DEFLATE THE ABDOMINAL CAVITY BEFORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 850307 | VERSAONE BLADED 5MM STD FIX X6 | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | COVIDIEN, FORMERLY US SURGICAL A DIVISON | B5STF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |