FDA Adverse Event Malfunction Summary report: N

OPERON

MDR report key: 2035908 · Received March 3, 2011

Report

Report Number: 1220685-2011-00001
Event Type: Malfunction
Date Received: March 3, 2011
Date of Event: February 7, 2011
Report Date: March 2, 2011
Manufacturer: BERCHTOLD CORP.
Product Code: FWY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE TABLE WAS EVALUATED BY A BERCHTOLD SVC REP ON-SITE. THE BACK-UP HYDRAULIC LINE GOT CAUGHT ON THE UPPER TREND CYLINDER FITTING, AND WHILE THE TABLE WAS MOVING, IT PULLED ON THE BACK-UP HYDRAULIC MANIFOLD CONNECTION, WHICH RESULTED IN A HYDRAULIC LEAK THAT ALLOWED THE BACK SECTION TO DRIFT DOWN. THE HYDRAULIC LINE WAS REPLACED AND THE TABLE WAS TESTED TO BE FUNCTIONING PROPERLY.

Description of Event or Problem · 1

THE DATA AND INFO CONTAINED HEREIN IS BEING SUBMITTED TO THE FDA TO COMPLY WITH THE REGULATIONS (21 CFR PART 803) PERTAINING TO MEDICAL DEVICE REPORTING. THIS MDR IS BASED ON PRELIMINARY INFO REC'D BY BERCHTOLD, WHO HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE EVENT. THIS MDR IS, THEREFORE, NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION THAT A REPORTABLE EVENT OCCURRED OR THAT ANY BERCHTOLD PRODUCTS WERE CAUSALLY RELATED TO THE EVENT. DURING A PROCEDURE WITH A REVERSE ORIENTED PT ON THE TABLE IN TRENDELENBURG, THE TABLE WAS ACTIVATED TO MOVE INTO THE REVERSE TRENDELENBURG POSITION. DURING THIS MOVEMENT, THE BACK SECTION STARTED TO MOVE DOWN WITHOUT BEING ACTIVATED, AND HYDRAULIC FLUID WAS NOTED TO BE ON THE FLOOR. AT THIS TIME, THE TABLE STOPPED RESPONDING TO COMMANDS. THE PT WAS MOVED ONTO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED. NO INJURY RESULTED FROM THIS PRODUCT PROBLEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPERON	SURGICAL TABLE	FWY	BERCHTOLD CORP.	B 810

Patients

Seq	Age	Sex	Outcome	Treatment
1