PHOTONGUIDE, WIDE/FLAT
Received Dec 6, 2024 · Event occurred Jul 1, 2023
Report 0002936485-2024-00924 · MDR key 20868282
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Stryker Endoscopy-san JoseCatalog number
104015
Lot number
22264W
Product problems
- Melted
- Overheating of Device
- Melted
- Overheating of Device
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: PIECE MELTED DURING SURGERY. PROBABLE ROOT CAUSE: -INGRESS OF BLOOD IN PHOTONGUIDE ADAPT CAUSES OPTICAL FIBERS TO MELT -INADEQUATE OPTICAL DESIGN OR MATERIAL -INADEQUATE SURFACE QUALITY -WAVEGUIDE FACE IS OBSTRUCTED BY BLOOD, TISSUE, OR OTHER MATERIAL -USE ERROR OF CONNECTING INAPPROPRIATE LIGHT SOURCE OR USING INAPPROPRIATE LIGHT SOURCE SETTINGS -USE ERROR OF USING WAVEGUIDE WITHOUT A RETRACTOR -USE ERROR OF LEAVING DEVICE UNATTENDED WHILE ILLUMINATED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT MELTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT MELTED.