FIVE S 3.5X65, STERILE, FOR SINGLE USE,
Received Jul 8, 2024 · Event occurred Jun 10, 2024
Report 9610617-2024-00199 · MDR key 19697788
Device
Generic name
Five S 3.5x65, Sterile, For Single Use,
Manufacturer
Karl Storz Se & Co. KgModel number
091361-06Catalog number
091361-06
Lot number
500099740
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PER INVESTIGATION BY THE MANUFACTURING SITE: AS NO PRODUCT HAS BEEN RETURNED A FINAL DETERMINATION OF THE ROOT CAUSE IS NOT POSSIBLE. IN SIMILAR CASES WITH THE SAME PRODUCT, EXCESSIVE FORCE DURING APPLICATION LEAD TO DAMAGES AT THE ENDOSCOPE. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Additional Manufacturer Narrative
THE DEVICE WAS USED AND CONTAMINATED, AND THUS WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING DOUBLE-LUMEN PLACEMENT PROCEDURE ON (B)(6) 2024, THE DISTAL TIP OF THE SCOPE BROKE. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP STETHOSCOPE.