SOFMED

Report

Report Number: 8020045-2008-00006
Event Type: Injury
Date Received: July 22, 2008
Report Date: July 18, 2008
Manufacturer: LEONHARD LANG GMBH
Product Code: ODR
PMA / PMN Number: K030362
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

AS THE DEVICE INVOLVED HAS NOT BEEN AVAILABLE, ONLY THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN TESTED THERMALLY, ELECTRICALLY, FOR THEIR ADHESION AND INSPECTED VISUALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN THE LIMITS AND NO FAULTS COULD BE DETECTED. AS NO FURTHER INFO HAS BEEN MADE AVAILABLE SO FAR DESPITE OF OUR EFFORTS, NO CONCLUSIONS AS TO THE CAUSE OF THE INCIDENT CAN BE DRAWN. THIS INCIDENT IS REPORTED ON THE BASIS OF DOUBT ABOUT THE SEVERITY OF THE INJURY AND MIGHT WELL BE NOT REPORTABLE.

Description of Event or Problem · 1

DURING AN ELECTROSURGICAL PROCEDURE IN THE HOSPITAL, A SPLIT GROUNDING PLATE WAS USED. THE CUSTOMER PROVIDED TWO PHOTOS SHOWING A FEMALE LEG ON WHICH A REDDENING APPROX 11 CM IN LENGTH AND 6 CM IN WIDTH CAN BE SEEN. IT HAS THE APPROXIMATE SHAPE OF THE GROUNDING PLATE USED. THE CUSTOMER COMPLAINED IT AS A DEFECT. NO FURTHER INFO HAS BEEN MADE AVAILABLE SO FAR ON THE PT, BRAND AND MODEL OF THE ELECTROSURGICAL GENERATOR USED AND ITS SAFETY FEATURES, THE NATURE OF THE SURGICAL PROCEDURE AND ITS DURATION, THE SKIN PREPARATION AND THE POSITION AND ORIENTATION OF THE GROUNDING PLATE RELATIVE TO THE SURGICAL AREA. IT IS ALSO UNCLEAR, WHAT HAS CAUSED THE REDDENING AND OF WHAT SEVERITY IT WAS. THE PHOTOS SEEM TO INDICATE A FIRST DEGREE BURN. UPON REPEATED REQUESTS THE ONLY INFO PROVIDED IS THAT THE INJURY HAD NOT BEEN SPECIALLY TREATED AND HAD HEALED QUICKLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SOFMED	GROUNDING PLATE	ODR	LEONHARD LANG GMBH	RS28	80331-0807

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other