SURGISCOPE 15MM X 60MM

Description of Event or Problem

N/A

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED: THE CAMERA EXPERIENCED ISSUES WHEN THE PHYSICIAN ASSISTANT (PA), (THE ONLY PERSON NOT TRAINED), USED A BULB IRRIGATOR TO WASH THE CAMERA OFF, FLOODING THE CAMERA. WE HAVE SINCE RETRAINED THE OPERATIVE ROOM (OR) NURSING TEAM, SURGEONS AND PHYSICIAN ASSISTANTS (PA).

Additional Manufacturer Narrative

UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE SURGISCOPE WAS RETURNED FOR EVALUATION: DHR - 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.

Additional Manufacturer Narrative

ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013505638-2024-00001; 3013505638-2024-00002. A FACILITY REPORTED A SURGISCOPE 15MM X 60MM (ASX15/60) WAS EXTREMELY BLURRY. THE EVENT LED TO 30 MINUTES SURGICAL DELAY, HOWEVER, NO PATIENT CONSEQUENCES REPORTED.