SNAP CLAMP ASSEMBLY

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A FACILITY REPORTED THAT DURING A "HIGHLY COMPLEX DIGESTIVE SURGERY INVOLVING A PANCREATICODUODENECTOMY WITH VASCULAR RESECTION", THE SNAP CLAMP ASSEMBLY (4040) "SPONTANEOUSLY BROKE WHILE BEING MANIPULATED." THE BROKEN RETRACTOR DID NOT FALL INTO THE SURGICAL SITE, AND ALL BROKEN PARTS WERE SUCCESSFULLY RECOVERED. THERE WAS NO INJURY TO THE PATIENT; HOWEVER, A SURGICAL DELAY OF TWO HOURS WAS REPORTED.

Additional Manufacturer Narrative

THE SNAP CLAMP ASSEMBLY (4040) WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR DOCUMENTED A NONCONFORMANCE; THE AFFECTED COMPONENTS WERE REWORKED, AND THE REWORK WAS CONFIRMED TO HAVE NO ADVERSE EFFECT ON THE PRODUCT. A PHOTO OF THE SUSPECTED PRODUCT WAS PROVIDED BY THE CUSTOMER. INVESTIGATION OF THE PICTURE CONFIRMS THE FRACTURE. IT WAS LIKELY CAUSED BY MISHANDLING LEADING TO THE CLAMP BEING SUBJECTED TO HIGHER STRESS THAN IT WAS INTENDED TO BE ABLE TO WITHSTAND. NO RELEVANT CORRECTIVE ACTIONS WERE DISCOVERED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY WAS IDENTIFIED FOR CORRECTION AS A RESULT OF THIS COMPLAINT INVESTIGATION.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

THE SNAP CLAMP ASSEMBLY (4040) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE ANALYSIS OF THE CLAMP FOUND THAT IT CONTAINS SIGNIFICANT CORROSION ON THE INTERNAL CLAMP SURFACES, AS SEEN IN THE ATTACHED PICTURE. THIS RETRACTOR WAS REPORTEDLY USED ON OTHER OCCASIONS. BASED ON THIS AND BASED ON ANALYSIS OF THE RETURNED CLAMP, IT IS MOST LIKELY THAT IMPROPER/INADEQUATE DRYING FOLLOWING THE CLEANING AND/OR STERILIZATION PROCESS CAUSED THE CLAMP TO CORRODE, LEADING TO THE WEAKENING AND ULTIMATELY THE FRACTURE OF THE CLAMP IN THE LOCATION OF THE CORROSION. THE 4040 SNAP CLAMPS MUST BE THOROUGHLY DRIED FOLLOWING THE WASHING AND STERILIZATION PROCESS AS PER INSTRUCTION FOR USE (IFU) 40-9015 TO PREVENT RESIDUAL WATER FROM CORRODING THE 4040 SNAP CLAMPS.

Description of Event or Problem

N/A.