FDA Adverse Event
Malfunction
Summary report: N
ETRIO
MDR report key: 2913368
·
Received January 14, 2013
Report
- Report Number
- 3005075853-2013-00194
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 5, 2012
- Report Date
- January 3, 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PACKAGING LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT OR DETERMINE THE CAUSE POTENTIAL/PROBABLE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
RECEIVED USER FACILITY MEDWATCH# (B)(4) THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, TIP WAS BROKEN OR LOOSE AND WOULD NOT WORK PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21418 | ETRIO | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ETHICON ENDO-SURGERY, LLC. | UNK | J4CJ7J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | GENERATOR |