FDA Adverse Event
Malfunction
Summary report: N
ETRIO
MDR report key: 3626316
·
Received February 13, 2014
Report
- Report Number
- 3005075853-2014-01043
- Event Type
- Malfunction
- Date Received
- February 13, 2014
- Date of Event
- February 6, 2014
- Report Date
- February 7, 2014
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K072177
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE 1ST DEVICE BECAME ACTIVATED INTERMITTENTLY WITHOUT PRESSING THE HAND SWITCH. THE SAME EVENT OCCURRED IN THE 2ND DEVICE. . A COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96570 | ETRIO | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ETHICON ENDO-SURGERY, LLC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR |