FDA Adverse Event
Malfunction
Summary report: N
ETRIO
MDR report key: 2963922
·
Received February 15, 2013
Report
- Report Number
- 3005075853-2013-00659
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 13, 2013
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE WAS BEING USED ON TISSUE AND THE ELECTRODE ON THE JAW CAME OFF DURING THE CASE. NO PIECE FELL INTO THE PATIENT. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED AFTER THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67850 | ETRIO | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ETHICON ENDO-SURGERY, LLC. | UNK | J4CT7F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |