FDA Adverse Event Malfunction Summary report: N

SYSTEM 83 PLUS 2

MDR report key: 4987855 · Received August 10, 2015

Report

Report Number: 3007082252-2015-00006
Event Type: Malfunction
Date Received: August 10, 2015
Date of Event: March 13, 2015
Report Date: March 13, 2015
Manufacturer: CUSTOM ULTRASONICS INC.
Product Code: FEB
PMA / PMN Number: K983017
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED SYMPTOM WAS POSSIBLY ATTRIBUTED TO USER ERROR BY EITHER NOT APPLYING ALCOHOL INJECTION INTO THE SCOPE AT THE COMPLETION OF REPROCESSING IN THE SYSTEM 83 PLUS, IMPROPER DRYING METHODS, OR USE OF NON-OEM FILTERS. THE FACILITY RECEIVED RE-INSERVICE TRAINING REGARDING USE OF THE SYSTEM 83 PLUS WASHER / DISINFECTOR AND STORAGE CABINET ON (B)(6) 2015. AT THE TIME OF THIS REPORT THEE ARE NO PATIENT INJURIES. CUSTOM ULTRASONICS IS REPORTING THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

ON (B)(6) 2015, CUSTOM ULTRASONICS RECEIVED A CALL REQUESTING A PREVENTATIVE MAINTENANCE BE COMPLETED. THE CUSTOMER ALSO STATED THAT A COLONOSCOPE AND AN ERCP SCOPE WERE REMOVED FROM A SCOPE STORAGE CABINET AND WHEN TESTED WERE FOUND TO PRODUCE ((B)(6) 2015 PSEUDOMONAS AERUGINOSA-CF160 AND GIF2T160, (B)(6) PSEUDOMONAS STENOTROPHOMONAS- CF160 AND TJF160VF) POSITIVE CULTURES. ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6) 2015: ON (B)(6) 2015, CF160 AND GIF2T160 SCOPES WERE CULTURED AND TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA IN BOTH AUXILIARY CHANNEL PORTS. ANOTHER TWO MODELS, CF160 AND TJF160VF, WERE FOUND TO BE POSITIVE ON MARCH 10TH. THESE SCOPES WERE TESTED AT THE AUXILIARY CHANNEL PORTS (ELEVATOR CHANNEL FOR TJF160VF) AND WERE POSITIVE FOR PSEUDOMONAS STENOTROPHOMONAS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
522940	SYSTEM 83 PLUS 2	ENDOSCOPE WASHER DISINFECTOR	FEB	CUSTOM ULTRASONICS INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1