InjuryGEI
VALLEYLAB ELECTROCAUTERY UNIT & ACCESSORIES
Received Jun 28, 2002 · Event occurred Jun 20, 2002
Report 402442 · MDR key 402442
Device
Generic name
Electrocautery Unit/accessories
Manufacturer
ValleylabModel number
VALLEYLAB FORCE FXCatalog number
FORCE FX
Lot number
M248320
Product problems
- Melted
- Replace
Patient
6 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHILE CAUTERIZING ADENOIDS WITH VALLEY LAB SUCTIONING CAUTERY DISPOSABLE, DR REMOVED SUCTION CAUTERY FROM PT'S ORAL CAVITY AND TIP AND SHEATH AT TIP APPEARED TO BE MELTED. VALLEY LAB ELECTROCAUTERY UNIT SETTING - 50 COAG. DISPOSABLE REMOVED FROM FIELD, BAGGED. DR THEN USED HC CAUTERY (VALLEY LAB PRODUCT) WITH TIP MELTING. VALLEY LAB ELECTROCAUTERY UNIT SETTING - 25 COAG. DISPOSABLE REMOVED FROM FIELD, BAGGED. PHYSICIAN EXAMINED SURGICAL SITE AND FOUND NO EVIDENCE OF INJURY. CAUTERY UNIT AND DISPOSABLES SENT TO BIOMED.