OPTICAL BIOPSY FORCEPS
Received Sep 3, 2020 · Event occurred Aug 4, 2020
Report 9610617-2020-00098 · MDR key 10487715
Device
Generic name
Optical Grasping Forceps
Manufacturer
Karl Storz Se & Co. KgModel number
27072ACatalog number
27072A
Lot number
NR
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
76 YR
- No Consequences Or Impact To Patient
- Unspecified Kidney or Urinary Problem
- No Consequences Or Impact To Patient
- Unspecified Kidney or Urinary Problem
Narrative
Additional Manufacturer Narrative
THE EVALUATION OF THE RETURNED INSTRUMENT DATE CODE NR08(01/2018) DISTAL END OF SHAFT IS CRUSHED AND TIP AND JAWS ARE MISSING.
Additional Manufacturer Narrative
PRODUCT HAS NOT BEEN RETURNED AND THEREFORE, COULD NOT BE EVALUATED.
Description of Event or Problem
ALLEGEDLY, PER THE CUSTOMER DURING A BLADDER STONE PROCEDURE THE FORCEPS CUP BENT AND WOULD NOT OPEN. PER THE CUSTOMER "WE BROKE CUP TO REMOVE FROM SHEATH", NOTHING FELL INSIDE THE PATIENT AND PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION REQUIRED OR HARM TO THE PATIENT.