MalfunctionFDS
GYN ROTATING CONTINUOUS FLOW RESEC SHEATH
Received Aug 22, 2014 · Event occurred Aug 6, 2014
Report 2951238-2014-00394 · MDR key 4077554
Device
Generic name
Resectoscope Sheath
Manufacturer
Gyrus Acmi Inc.Model number
GERIS-CF25Catalog number
GERIS-CF25
Lot number
UNK
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE CERAMIC TIP OF THE RESECTOSCOPE SHEATH BROKE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.