inforMED
InjuryLMD

OR1 RACK KONFIGURIERT, NEO, 40 BIS 47HE

Received Dec 16, 2022 · Event occurred Nov 30, 2022

Report 9610617-2022-00335 · MDR key 15997191

Device

Generic name

Or1 Rack Konfiguriert

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE EVENT OCCURRED IN GERMANY. AFTER CONSULTING WITH THE NURSING STAFF PRESENT IN THE ROOM, THEY HAD PREVIOUSLY EXPERIENCED SIGNAL PROBLEMS ON SOME MONITORS. HOWEVER, AFTER RESTARTING THE SYSTEM, THESE WERE RESOLVED, AND THE SURGERY WAS STARTED. SHORTLY AFTER THE PROCEDURE BEGAN, THE IMAGE SIGNAL FAILED ON ALL MONITORS. THE AV CONTROL LIGHT WAS NOT ACTIVE. HOWEVER, THE DOCUMENTATION (AIDA) CONTROL LIGHT REMAINED ON. THE BACKUP LINE WAS NOT USED. THE CAMERA SYSTEM AND ENDOSCOPIC EQUIPMENT WERE FUNCTIONAL AND OPERATING. THE PATIENT WAS STERILELY DRAPED AND TAKEN TO ANOTHER OR TO COMPLETE THE SURGERY. NO FURTHER NEGATIVE IMPACT WAS REPORTED.

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE EVENT OCCURRED IN GERMANY. AFTER CONSULTING WITH THE NURSING STAFF PRESENT IN THE ROOM, THEY HAD PREVIOUSLY EXPERIENCED SIGNAL PROBLEMS ON SOME MONITORS. HOWEVER, AFTER RESTARTING THE SYSTEM, THESE WERE RESOLVED, AND THE SURGERY WAS STARTED. SHORTLY AFTER THE PROCEDURE BEGAN, THE IMAGE SIGNAL FAILED ON ALL MONITORS. THE AV CONTROL LIGHT WAS NOT ACTIVE. HOWEVER, THE DOCUMENTATION (AIDA) CONTROL LIGHT REMAINED ON. THE BACKUP LINE WAS NOT USED. THE CAMERA SYSTEM AND ENDOSCOPIC EQUIPMENT WERE FUNCTIONAL AND OPERATING. THE PATIENT WAS STERILELY DRAPED AND TAKEN TO ANOTHER OR TO COMPLETE THE SURGERY. NO FURTHER NEGATIVE IMPACT REPORTED. A KARL STORZ EMPLOYEE WAS ON SITE AND INVESTIGATED THE UNIT IN QUESTION. ACCORDING TO THE SERVICE REPORT (DATED 2022-12-01), NO MALFUNCTION COULD BE CONFIRMED. THE DESCRIBED ERROR "NO MORE SIGNALS WERE DISPLAYED ON ALL MONITORS" COULDN'T BE CONFIRMED. THE INITIAL ASSUMPTION THAT THE DEVICE IS A MEDICAL DEVICE WAS BASED ON A LINKING ERROR IN OUR DATABASE. IN FACT THE DEVICE IS NOT CLASSIFIED AS MEDICAL DEVICE DUE TO THE FOLLOWING: "THE KARL STORZ ITEM WCONRACK1, SERIAL NUMBER (B)(6), IS A NON-MEDICAL DEVICE ACCORDING TO MEDICAL DEVICE REGULATION. THE ITEM GROUP WCONRACK CONSISTS OF INSTALLATION EQUIPMENT FOR MEDICAL DEVICES AND NON-MEDICAL DEVICES, TO ALLOCATE THESE SUFFICIENTLY CLOSE TO THE OR. THE INSTALLATION DEVICE DOES NOT FULFILL A DEFINED MEDICAL INTENDED PURPOSE AND THUS IS NOT A SYSTEM OF MEDICAL DEVICES. THE MEDICAL DEVICES AND NONMEDICAL DEVICES SPECIFIED IN THE MATERIAL LIST OF WCONRACK1, SERIAL NUMBER (B)(6) ARE CERTIFIED ACCORDING TO THE RESPECTIVELY APPLICABLE REGULATIONS." THE CASE IS THEREFORE DEEMED AS NOT REPORTABLE UNDER THE MEDICAL DEVICE REGULATIONS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).