MalfunctionFTJ

ADULT COLONOSCOPE

Received Nov 9, 2016 · Event occurred Aug 3, 2016

Report MW5065958 · MDR key 6092479

Device

Generic name

Adult Colonoscope

Manufacturer

Olympus America, Inc.

Product problems

Break

Patient

63 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING COLONOSCOPY, CABLE ON LARGE WHEEL OF SCOPE BROKE. THE SCOPE WAS ALMOST AT THE CECUM, BUT NOT CLOSE ENOUGH TO COMPLETE EXAM. SCOPE HAD TO BE SWITCHED TO ANOTHER SCOPE CAUSING THE EXAM TO BE STARTED ALL OVER AGAIN PATIENT HAD TO RECEIVE ADDITIONAL SEDATION AND PROLONG PROCEDURE TIME. THE ADULT COLONOSCOPE WAS RETURNED TO OLYMPUS FOR REPAIR ON OR ABOUT 08/05/2016. THE PATIENT TOLERATED THE ADDITIONAL PROCEDURE TIME AND MEDICATIONS WITHOUT ISSUE.