THE CUSTOMER REPORTS THAT THE ORIGINAL PRODUCT WAS A PILLING # ((B)(4)). WHEN CROSS-REFERENCED TO USE YOUR PRODUCT, WE ORDERED A JARIT 505-200. SINCE THEN, THE GYN CLINIC HAS HAD PT'S RETURNING DUE TO BLEEDING FOR CAUTERIZATION OF THE PUNCTURE SITES. THE DR'S LOOKED CLOSELY AND FOUND THAT THIS REPLACEMENT IS NOT THE SAME AS THE PILLING PRODUCT. IT IS MORE ROUNDED AT THE TIP. NOT A CORRECT CROSS-REFERENCE THE DEVICE HAS BEEN IN USE BY THE CUSTOMER SINCE (B)(6) 2008 THROUGH (B)(6), 2009.
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Patient 1
PLEASE REFER TO MANUFACTURER'S COMPLAINT INVESTIGATION REPORT. ADDITIONAL INFORMATION FROM IMPORTER REPORT: SCHROEDER TENACULUM FCPS 10. CATALOG# 505200. (B)(4). THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. CONCLUSION: THE MANUFACTURER FINDS ABSOLUTELY NO EVIDENCE AND HAS NO EXPLANATION FOR HOW THE SCHROEDER TENACULUM FORCEPS MIGHT HAVE CAUSED THE BLEEDING OTHER THAN IMPROPER USE AND HANDLING OF THE DEVICE. WE ALSO FAIL TO SEE THE CONNECTION WITH REGARDS TO THE CAUTERIZATION PROCEDURE. FURTHERMORE, THE EXTERIOR ROUNDED INSTRUMENT TIPS ARE DESIGNED TO MAKE IT A SAFER DEVICE. THE FIVE (5) RETURNED INSTRUMENTS MEET ALL QUALITY AND FUNCTIONAL SPECIFICATIONS. IN VIEW OF THE STATISTICS, I.E. A RETURN OF 0.2% OF ALL INSTRUMENTS SOLD, WE CANNOT DETECT A PROBLEM THAT MIGHT CALL FOR CORRECTIVE OR PREVENTIVE ACTION (PLEASE SEE BELOW REPRESENTATIVE PHOTOGRAPHS OF THE RETURNED DEVICES).