8 mm Monopolar Curved Scissors (A.K.A. Hot Shears)

Starting date:

May 31, 2013

Posting date:

July 23, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-34691

• 
  Reason
• 
  Affected products

Recalled products

1. 8 mm Monopolar Curved Scissors (A.K.A. Hot Shears)

Reason

It has been identified that a potential for some units of MCS (Monopolar Curved Scissors) versions -09 and -10 instruments to develop very small cracks ("micro-cracks") near the distal (scissor) end.  This may create a pathway for electrosurgical energy to leak to tissue nearby during surgery and potentially cause thermal injury. The results of internal failure analysis showed that new instruments (as would be delivered from intuitive surgical, inc. to a customer) do not exhibit micro-cracks and that the micro- cracks first appear after reprocessing. The cracks only appeared within a narrow area approximately 7 cm from the tip, confined to an approximately 1 cm section of the shaft.

Affected products