FDA Adverse Event
Malfunction
Summary report: N
OPERON
MDR report key: 2232940
·
Received July 28, 2011
Report
- Report Number
- 8010153-2011-00001
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 24, 2011
- Report Date
- July 22, 2011
- Manufacturer
- BERCHTOLD GMBH & CO. KG
- Product Code
- FWY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE TABLE WAS EVALUATED BY A BERCHTOLD CORP. SERVICE TECHNICIAN ON (B)(4) 2011 AFTER THE INCIDENT AT THE LOCATION WHERE THE INCIDENT OCCURRED. THE TABLE IS IN GOOD PHYSICAL CONDITION. ALL THE TABLE FUNCTIONS OPERATED AS EXPECTED WITHOUT PROBLEMS, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE TABLE HAS BEEN RETURNED TO THE BERCHTOLD CORPORATION FACILITY IN (B)(4) FOR FURTHER EVAL.
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE, WHEN THE TRENDELENBURG FUNCTION BUTTON WAS PRESSED, THE TABLE TOP WAS REPORTED TO HAVE DROPPED STRAIGHT DOWN BETWEEN 6" - 14". THERE WAS NO PT INJURY REPORTED, BUT THE PROCEDURE WAS ABORTED AFTER THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERON | SURGICAL TABLE | FWY | BERCHTOLD GMBH & CO. KG | D850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |