SPECULUM MCO981D DEVEZE
Received Nov 15, 2017
Report 2523190-2017-00136 · MDR key 7032551
Device
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 13, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; THE LASER WELDING BETWEEN SPECULUM AND FRAME IS CRACKED. THERE IS NOT FRAGMENT. A THOROUGH OBSERVATION OF WELDING DID NOT HIGHLIGHTED WELDING DEFECT. DHR REVIEW; (ALWAYS INCLUDE DHR REVIEW, IF LOT NUMBER OR DEVICE NOT PROVIDED, EXPLAIN WHY). NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. COMPLAINTS HISTORY; NO ADVERSE TREND - FIRST OCCURRENCE OF THIS RISK FOR THIS DEVICE. CONCLUSION: THE ORIGIN OF THE CRACK CANNOT BE DETERMINED WITH CERTAINTY. THE MOST PROBABLE CAUSE IS AN EXCESSIVE CONSTRAINT ON THE SPECULUM.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE SEAL BROKE. PRODUCT WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY REPORTED AND THE EVENT LEAD TO 45 MINUTES SURGICAL DELAY.