SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE IS UNKNOWN AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE ) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER/LOT # WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED ¿PACKAGING TORN WHEN TRYING TO OPEN¿ ISSUE COULD NOT BE DETERMINED, HOWEVER, STERILE PACKAGES THAT ARE ADDITIONALLY HEAT-SEALED AND HAVE A HIGHER SEAL STRENGTH THAN THOSE THAT ARE NOT ADDITIONALLY HEAT-SEALED. THEREFORE, THE STERILE PACKAGES ARE MORE LIKELY TO BE DIFFICULT TO OPEN. THE ISSUE WAS LIKELY THE RESULT OF USER HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.