FDA Adverse Event Malfunction Summary report: N

STRYKER ENDOSCOPY

MDR report key: 2182293 · Received July 25, 2011

Report

Report Number: MW5021496
Event Type: Malfunction
Date Received: July 25, 2011
Date of Event: July 7, 2011
Report Date: July 18, 2011
Manufacturer: STRYKER ENDOSCOPY
Product Code: HRX
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: TX, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

PT HAD ARTHROSCOPIC SURGERY ON THEIR RIGHT KNEE. DURING THE PROCEDURE, THE PT HAD AN EPISODE OF ATRIAL FLUTTER. THE PT'S OTHER VITAL SIGNS REMAINED STABLE THROUGHOUT AND NO FURTHER TREATMENT OR INTERVENTION WAS GIVEN FOR THE ATRIAL FLUTTER. THE PARENTS WERE NOTIFIED THAT THE CHILD HAD THIS EPISODE OF ATRIAL FLUTTER AND THEY WERE ADVISED TO F/U WITH A CARDIOLOGIST. THE PUMP CREATED A FALSE RHYTHM ON THE EKG. THIS EVEN OCCURRED WHEN UNPLUGGED AND RUNNING ON BATTERIES. IN THE VERY NEXT CASE, THERE WAS AGAIN ARTIFACT ON THE EKG. TROUBLESHOT WITH THE HELP OF MEDICAL EQUIPMENT SPECIALIST AND DETERMINED THE PROBLEM WAS RELATED TO THE ARTHROSCOPY PUMP (WHEN THE PUMP WAS RUNNING AT A HIGH SPEED, ARTIFACT WAS PRESENT). REPLACED ALL COMPONENTS OF THE EKG SYSTEM AND THE PROBLEM REMAINED. PUMP TUBING WAS RELOCATED RELATIVE TO THE PT'S EKG LEADS AND THE PROBLEM WENT AWAY. WHEN DISCUSSED WITH THE ANESTHESIOLOGIST, HE REVEALED THIS SAME EVENT OCCURRED IN THE VERY NEXT CASE AS WELL. VERIFICATION MADE WITH ANESTHESIOLOGIST AND RECOVERY ROOM NURSE THAT THERE WAS NO RECURRENCE OF THE WAVEFORM POST-OPERATIVELY AND NO CLINICAL INTERVENTIONS WERE PERFORMED AS A RESULT OF THE APPARENT ARRHYTHMIA. ARTHROSCOPY PUMP WAS REMOVED FROM SVC AND THE MFR WAS CONTACTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STRYKER ENDOSCOPY	FLOSTEADY MODEL 150	HRX	STRYKER ENDOSCOPY	350-800-001

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR