FIVE S 3.5X65, STERILE, FOR SINGLE USE,
Received Oct 24, 2023 · Event occurred Nov 19, 2020
Report 9610617-2023-00321 · MDR key 17999734
Device
Generic name
Five S 3.5x65, Sterile, For Single Use,
Manufacturer
Karl Storz Se & Co. KgModel number
091361-06Catalog number
091361-06
Product problems
- Defective Component
- Defective Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS RETURNED FOR INVESTIGATION. EVALUATION FINDINGS: DEFECT LOCATION: VIDEO, VERTEBRA AND UNSPECIFIED. DEFECT TYPE: MEASURE OUT OF TOLERANCE AND NO IMAGE. CAUSE CODE: NOT PROVIDED/ FAILURE NOT CLASSIFIABLE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED, THAT NO PICTURE IS PRODUCED ON THE MONITOR AND THE LIGHT WAS INTERMITTENT. NO HARM TO THE PATIENT, SURGEON OR THIRD PARTY.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY: THE INITIAL MDR HAD THE CORRECT UDI NUMBER BUT THE FIRST DIGIT "0" WAS OMITTED. PLEASE SEE SECTION D4 OF THIS MDR FORM FOR THE UPDATED UDI NUMBER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).