SURGISCOPE 15MM X 80MM
Received Sep 13, 2024 · Event occurred Aug 23, 2024
Report 3013505638-2024-00002 · MDR key 20212846
Device
Generic name
Aurora Surgiscope System
Manufacturer
Rebound Therapeutics CorpCatalog number
ASX15/80
Lot number
735877
Product problems
- Optical Problem
- Optical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATED FIELDS: D9, G3, G6, H2, H3, H11. ADDITIONAL INFORMATION RECEIVED: THE CAMERA EXPERIENCED ISSUE DUE TO THE PLACEMENT OF THE TUBE AND IRRIGATION. THE ANGLE OF THE TUBE PUT THE CAMERA ON THE DOWNSIDE OF THE OPENING OF THE TUBE. THE SURGEON USED A BULB IRRIGATOR AND PUT WATER INTO THE CAMERA SYSTEM. WE HAVE SINCE RETRAINED THE OPERATIVE ROOM (OR) NURSING TEAM, SURGEONS AND PHYSICIAN ASSISTANTS (PA).
Additional Manufacturer Narrative
UPDATED FIELDS: D4(UDI#), D9, G3, G6, H2, H3, H6, H11. THE SURGISCOPE 15MM X 80MM (ASX15/80) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND NO ANOMALIES OCCURRED DURING THE MANUFACTURING OR PACKAGING OF THE DEVICE THAT COULD BE ATTRIBUTED TO THE COMPLAINT. FAILURE ANALYSIS - ALTHOUGH THE INITIAL IMAGE FROM ALL THE IMAGER WAS OUT OF FOCUS, THERE WERE NO FUNCTIONAL OR PERFORMANCE ISSUES FOUND WITH THE IMAGER. PRODUCT DEVELOPMENT WAS ABLE TO BRING THE TARGET IMAGE INTO FOCUS WITH THE IMAGER; THE TARGET IMAGE WAS FOCUSED AND NOT FOGGY OR HAZY. ROOT CAUSE - THE REPORTED COMPLAINT AND COMPLAINT SAMPLE EVALUATION INDICATE THAT THE BLURRY IMAGES OBSERVED BY CUSTOMER WERE DUE TO WATER INGRESS (I.E. KNOWN USER ERROR) AND FAILURE TO ADJUST THE FOCUS KNOB (NOTE: PRODUCT DEVELOPMENT EVALUATION FOUND THE FOCUS KNOB TO BE PROPERLY FUNCTIONING WITH NO DAMAGE NOTED).
Description of Event or Problem
N/A.
Description of Event or Problem
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013505638-2024-00001, 3013505638-2024-00003. A FACILITY REPORTED AN AURORA EVACUATOR (ID ASX15/80) WAS USED ON A ICH (INTRACEREBRAL HEMORRHAGE) EVACUATION PROCEDURE WHEN THE SCOPE'S CAMERA WAS EXTREMELY BLURRY FROM WATER GETTING INTO CAMERA AND LOST PROPER VISUALIZATION. THE EVENT LED TO 30 MINUTES SURGICAL DELAY; HOWEVER, NO PATIENT CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.