FDA Adverse Event
Malfunction
Summary report: N
AUTO ENDO5 ML
MDR report key: 4888471
·
Received July 2, 2015
Report
- Report Number
- 3003898360-2015-00473
- Event Type
- Malfunction
- Date Received
- July 2, 2015
- Date of Event
- June 1, 2015
- Report Date
- June 12, 2015
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GEF
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML, LOT #01C1100171, INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem · 1
ALLEGED EVENT: THE INNER COMPONENT IS BROKEN SO UNABLE TO LOAD CLIPS IN THE TIP. THE PROCEDURE WAS A CHOLECYSTECTOMY. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431477 | AUTO ENDO5 ML | APPLIER | GEF | TELEFLEX MEDICAL | 01C1100171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |