SPY-PHI DRAPES ONLY (PACK OF 20)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

IT WAS REPORTED THAT A RUBBER BAND POTENTIALLY REMAINS INSIDE THE PATIENT.

Description of Event or Problem

IT WAS REPORTED THAT A RUBBER BAND POTENTIALLY REMAINS INSIDE THE PATIENT.

Additional Manufacturer Narrative

ALLEGED FAILURE: "ONE OF THE RUBBER BAND WAS MISSING DURING PROCEDURE, AND THEY WANT TO KNOW WHETHER IT CAN BE DETECTED BY X-RAY OR NOT. IT WAS USED DURING OPEN SURGERY FOR LIVER. THEY ALSO WANT TO KNOW THE BIOCOMPATIBILITY OF THE RUBBER.". PROBABLE ROOT CAUSE(S): PRODUCT WAS NOT RECEIVED IN-HOUSE AT STRYKER ENDOSCOPY. BIOCOMPATIBILITY DATA FOR THE RUBBER BAND IS UNAVAILABLE AS THIS COMPONENT IT IS NOT INTENDED AS A PATIENT-CONTACTING PART. TESTING BY STRYKER REP IN CONJUNCTION WITH HOSPITAL STAFF FOUND THAT THE RUBBER BAND COULD BE VISUALIZED VIA X-RAY UNDER AN IN-VITRO SETTING. HOWEVER, ROOT CAUSE OF ISSUE CANNOT BE DETERMINED AS IT IS UNKNOWN AS TO WHETHER THE RUBBER BAND BROKE OR WAS ACCIDENTALLY DISLODGED DURING HANDLING OF CAMERA. IN ADDITION, THERE WERE NO UPDATES AS TO WHETHER THE RUBBER BAND WAS FOUND INSIDE THE PATIENT, NECESSITATING MEDICAL INTERVENTION. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED. IN THE EVENT THAT THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.