FDA Adverse Event Other Summary report: N

KARL STORZ

MDR report key: 1912730 · Received November 13, 2010

Report

Report Number: 9610617-2010-00034
Event Type: Other
Date Received: November 13, 2010
Date of Event: October 6, 2010
Report Date: November 10, 2010
Manufacturer: KARL STORZ GMBH & CO. KG
Product Code: FJL
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ID, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OUR LABELING INDICATES THAT ACTIVATION OF THE RESECTOSCOPE WHILE THE ELECTRODE IS NOT IN CONTACT WITH TISSUE MAY INCREASE THE POSSIBILITY OF CAPACITIVE COUPLING AND UNDESIRABLE AND REMOTE TISSUE EFFECTS. IN THIS CASE, SINCE THE ONLY CONTACT TO THE ABDOMEN WAS THE WORKING ELEMENT, THE CAPACITIVE COUPLING COULD CAUSE TISSUE EFFECTS, AND IF THERE IS ANY TISSUE BIOBURDEN CAUGHT BETWEEN THE ELECTRODE AND THE SHEATH, SERVING AS A BRIDGE, IT COULD RESULT IN AN UNINTENTIONAL BURN. OUR BENCH TEST WAS ABLE TO CONFIRM THAT. BASED ON INFORMATION RECEIVED FROM HOSPITAL THAT STATED NO PART OF THE INSTRUMENT WAS IN CONTACT WITH KNEE AND NO SPARKS WERE SEEN, WE CAN DRAW NO CONCLUSION REGARDING THE BURN TO THE KNEE. ALL INSTRUMENTS INVOLVED WERE HIPOTED AND PASSED. INSTRUMENT FUNCTIONED.

Description of Event or Problem · 1

ALLEGEDLY, AT THE CONCLUSION OF A HYSTEROSCOPY, DOCTOR PLACED RESECTOSCOPE ON THE PATIENT'S UNDRAPED ABDOMEN AREA. SHE THEN INADVERTENTLY DEPRESSED THE FOOTSWITCH WHICH ACTIVATED THE WORKING ELEMENT. THIS RESULTED IN A 3CM BURN TO THE ABDOMEN AREA WHERE THE HANDLE OF THE WORKING ELEMENT MADE CONTACT WITH SKIN, AND A 1 CM BURN ON THE INSIDE OF THE KNEE. HOSPITAL STATED THAT NO PART OF THE INSTRUMENT WAS IN CONTACT WITH THE KNEE. DOCTOR APPLIED SILVADENE SALVE TO THE BURNS; THE PATIENT IS HEALING WELL. PROCEDURE WAS COMPLETED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KARL STORZ	WORKING ELEMENT	FJL	KARL STORZ GMBH & CO. KG	27050E	EA

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Other