INNER SHEATH WITH CERAMIC BEAK
Received Feb 20, 2020
Report 9610617-2020-00024 · MDR key 9734564
Device
Generic name
Inner Sheath With Ceramic Beak
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
NQ05
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Tissue Damage
- Tissue Damage
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY THE MANUFACTURER, KARL STORZ IN (B)(4). AS PER THE EVALUATION: UPON EVALUATION IT WAS CONFIRMED THAT THE CERAMIC TIP IS BROKEN OFF. THE SHEATH SHOWS RESIDUALS OF THE ADHESIVE WHERE THE CERAMIC IS BROKEN OFF. THE TIP SHOWS A CONTINUOUS CRACK AND CERAMIC CHIPPING NEAR THE EDGE OF THE TIP. THE BREAK LINE STARTS AT THE EDGE OF THE TIP AND CONTINUES IN CIRCULAR WAY IN THE GLUING AREA. THE EDGE OT THE TIP SHOWS DISCOLORATION. THE DEVICE WAS MANUFACTURED IN JANUARY 2019. THE ROOT CAUSE MOST LIKELY WAS MECHANICAL DAMAGE TO THE CERAMIC TIP, WHICH LED TO THE CRACK AND SUBSEQUENTLY TO THE BREAKAGE. NO INDICATION FOR A MATERIAL OR MANUFACTURING RELATED ISSUE WAS FOUND DURING THE INVESTIGATION.
Description of Event or Problem
AS PER A VIGILANCE REPORT FILED WITH THE (B)(6) BY OUR PARENT COMPANY IN (B)(6), THE BEAK OF THE RESECTOSCOPE SHEATH BROKE OFF INSIDE THE BLADDER OF THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE BEAK ENTIRELY, BUT THE PATIENT SUFFERED SOME MILD URETHRAL TRAUMA AS A RESULT.