FDA Adverse Event Other Summary report: N

RE-USABLE ACTIVE CORD

MDR report key: 1611821 · Received February 18, 2010

Report

Report Number: 1519132-2010-00005
Event Type: Other
Date Received: February 18, 2010
Date of Event: January 4, 2010
Report Date: February 18, 2010
Manufacturer: GYRUS ACMI, INC.
Product Code: JOS
PMA / PMN Number: K890328
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

VISUAL EXAMINATION OF THE RAC-B INSTRUMENT FINDS THAT THE CORD IS COMPLETELY SEVERED JUST PROXIMAL TO THE ELECTRODE CONNECTOR BODY. ALL OF THE WIRES AT THE SEPARATED SECTION OF CORD EXHIBIT SIGNS OF CHARRING AND MELTING AT THEIR TIPS. THE WIRE BUNDLE INSIDE EACH END OF THE CORD APPEARS TO BE OTHERWISE INTACT. THE BALANCE OF THE INSULATED WIRE CORD IS IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF ABUSE OR EXCESSIVE WEAR. THE EXACT CAUSE OF THE FAILURE IS UNK. ANY SIGN OF EXTERNAL DAMAGE TO THE WIRE INSULATION WOULD HAVE BEEN LOST DUE TO THE MELTING AND CHARRING OF THE CORD. THE MOST LIKELY CAUSE OF THE FAILURE WOULD BE A CUT OR OTHER DAMAGE TO THE CORD IN THE FAILURE REGION, WHICH WOULD LEAD TO AN ELECTRICAL SHORT CONDITION DURING ACTIVATION TO ANY NEARBY GROUNDED OBJECT. THIS SHORT CONDITION WOULD THEN PRODUCE ARCING AND BURNING OF THE WIRES AND INSULATION, RESULTING IN THE ULTIMATE FAILURE OF THE CORD.

Description of Event or Problem · 1

DURING A TURP PROCEDURE AT (B)(6) HOSPITAL, THE SURGEON, RECEIVED A SHOCK WHEN ACTIVATING THE CAUTERY UNIT. OTHER DEVICES USED WITH THE RAC-B ACTIVE CORD HAVE NOT YET BEEN IDENTIFIED (MODEL OR MANUFACTURER) AND WE ARE STILL GATHERING INFORMATION FROM THE FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RE-USABLE ACTIVE CORD	RE-USABLE ACTIVE CORD	JOS	GYRUS ACMI, INC.	RAC-B

Patients

Seq	Age	Sex	Outcome	Treatment
1