ENDOSCOPE POSITION DETECTING UNIT
Received Oct 16, 2017 · Event occurred Sep 15, 2017
Report 8010047-2017-01475 · MDR key 6950696
Device
Generic name
Endoscope Position Detecting Unit
Manufacturer
Olympus Medical Systems Corp.Model number
UPD-3Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Skin Tears
- Skin Tears
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".
Additional Manufacturer Narrative
THE REFERENCED UPD-3 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, THEREFORE OMSC CANNOT EVALUATE THE UPD-3. THE EXACT CAUSE OF THIS PHENOMENON CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS THE POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO INAPPROPRIATE HANDLING OF THE UPD-3 BY THE FACILITY. OMSC CHECKED THE MANUFACTURE HISTORY OF THE UPD-3, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem
DURING THE COLONOSCOPY, WHEN THE RECEIVER DISH ARM OF THE UPD-3 WAS MOVED, THE PATIENT SUFFERED THE SKIN TEAR BECAUSE THE CABLE HOLDER ON THE RECEIVER DISH STAND CONTACTED WITH THE PATIENT. THE PATIENT WAS TREATED AND BANDAGED. THE COLONOSCOPY WAS COMPLETED.