UROPASS AS 10/12FR X 38 CM 5/BX
Received May 29, 2018 · Event occurred Apr 25, 2018
Report 3005975494-2018-00007 · MDR key 7549906
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY. DEVICE NOT YET RETURNED.
Description of Event or Problem
OLYMPUS ACCESS SHEATH (10/12 X 38CM) REF NO. 61038BX LOT NO. 09B1800252 WAS INSERTED BY SURGEON INTO URETER. HE THEN INSERTED A FLEXIBLE URETEROSCOPE, PULLED OUT BUT ON THE SECOND TIME HE TRIED TO INSERT, THERE WAS A RESISTANCE AND WHEN HE CHECKED THE SHEATH WAS BROKEN.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL INFORMATION RECEIVED FROM THE ORIGINAL EQUIPMENT MANUFACTURER. PLEASE SEE THE UPDATES TO SECTIONS: G4, G7, H2 AND H10. THE OEM PERFORMED A REVIEW OF THE DHR AND FOUND THAT THE 500038-28 BATCH 09B1800252 FAILURE UNIT WAS 1 OF THE (B)(4) 5-PACKS (970 UNITS) SHIPPED (B)(6)2018 . NO PRODUCT IS IN INVENTORY. NO OTHER COMPLAINT HAS BEEN MADE AGAINST THIS SHIPPED LOT. ALL OTHER UNITS PASSED ALL POST MOLDING TFX INSPECTION CRITERIA, INCLUDING ALL 1.5 IN-OZ HUB TORQUE TEST SAMPLES. NEITHER OF THESE 2 MOLDED HUB LOTS (09M1700154 AND 09A1800241WERE) OR THIS FINAL PRODUCT LOT (09B1800252) HAVE HAD A PREVIOUS FUNNEL-SHAFT BREAK COMPLAINT. A REVIEW OF COMPLAINTS FOR PRODUCT SHIPPED SINCE (B)(6)2017 SHOWS THIS HAS BEEN THE 4TH COMPLAINT OF THIS FAILURE MODE (B)(4) UNITS SHIPPED FROM (B)(6)2017 THRU (B)(6)2018). IT IS THE FIRST PRODUCT SHIPPED IN 2018 TO HAVE THIS TYPE OF PRODUCT COMPLAINT. IN ADDITION, THE OEM REPORTED THAT THE OCCURRENCE RATE OF THIS FAILURE MODE IS EXTREMELY LOW. THE CAUSE FOR THIS SPECIFIC COMPLAINT REMAINS UNKNOWN. NO FURTHER ACTION IS REQUIRED.
Additional Manufacturer Narrative
THE OEM CONFIRMED THE BROKEN FUNNEL PART DURING THEIR VISUAL INSPECTION OF THE PHOTOS SUPPLIED. THE OCCURRENCE RATE OF THIS FAILURE MODE IS EXTREMELY LOW. THE CAUSE FOR THIS SPECIFIC COMPLAINT REMAINS UNKNOWN AND IS CONSIDERED UNCONFIRMED WITH REGARDS TO TELEFLEX MATERIAL AND MANUFACTURING PROCESSING.