FDA Adverse Event
Injury
Summary report: N
ECHELON*FLEX60 ARTICULATING
MDR report key: 2873756
·
Received December 14, 2012
Report
- Report Number
- 3005075853-2012-05723
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 28, 2012
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K081146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; AFTER MULTIPLE ATTEMPTS THE DEVICE WAS NOT RETURNED FOR EVALUATION.THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LUNG NODULE EXTRACTION PROCEDURE, THE DEVICE WAS JAMMED. THE SURGEON CANNOT EXTRACT THE DEVICE, SO HE HAD TO OPEN THE PATIENT AND EXTRACT THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON*FLEX60 ARTICULATING | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | J4CC7A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |