MalfunctionEMH
PK CUTTING FORCEPS, 5MM, 33CM
Received Jun 2, 2016 · Event occurred Feb 26, 2016
Report 3003790304-2016-00004 · MDR key 5694404
Product problems
- Thermal Decomposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
LEFT SIDE OF BLUE COAG BUTTON HAS NO TACTILE FEEL, RIGHT SIDE IS GOOD. COMPLAINT IS CONFIRMED, UPON PLUGGING THE DEVICE INTO THE GENERATOR IT ACTIVATES WITH OUT TOUCHING THE BLUE COAG BUTTON. REMOVED COAG BUTTON, COLLAPSED LEFT SIDE DOME SWITCH ON THE FLEX CIRCUIT.
Description of Event or Problem
LOT PW301382. THE INSTRUMENT BURNT WITHOUT CONTACT. (B)(4).