FDA Adverse Event
Malfunction
Summary report: N
FORCEPS MCL19BIS RIGHT BOUCHAYER HEART
MDR report key: 3782168
·
Received April 30, 2014
Report
- Report Number
- 9680837-2014-00037
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- March 17, 2014
- Report Date
- April 8, 2014
- Manufacturer
- XOMED MICROFRANCE MFG
- Product Code
- KAE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE TIP OF THE FORCEPS IS ¿BROKEN OFF¿. IT WAS CONFIRMED WITH THE FACILITY THAT THE TIP WAS BENT, NOT BROKEN. THERE WAS NO PATIENT IMPACT. PRODUCT ANALYSIS FOUND THAT THE MOBILE JAW IS BROKEN AND A FRAGMENT IS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259702 | FORCEPS MCL19BIS RIGHT BOUCHAYER HEART | FORCEPS, ENT | KAE | XOMED MICROFRANCE MFG | MCL19BIS | 100403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |