CYSTOURETHROSCOPE STANDARD OBTURATOR, 21FR
Received Sep 17, 2019 · Event occurred Aug 20, 2019
Report 2951238-2019-01121 · MDR key 9076879
Device
Generic name
Cystourethroscope Standard Obturator
Manufacturer
Gyrus Acmi, IncModel number
E121-OLot number
FT
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
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). PLEASE THE UPDATES IN SECTIONS: G4, G7, H2 AND H10. THE DHR REVIEW OF THE E121-O MANUFACTURED JUNE 2004, DID NOT FIND ANY DEFECTS, NONCONFORMING ISSUE OR ANY CORRECTIVE ACTION ISSUES DURING THE ASSEMBLY BUILD OF THE DEVICE
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THE INSTRUCTION MANUAL STATES ''EXAMINE THIS DEVICE PRIOR TO USE. DO NOT USE IF DAMAGE IS FOUND. DO NOT USE AN INSTRUMENT THAT FAILS TO MEET THE CRITERIA STATED IN THE LABELING OR THAT HAS BEEN DAMAGED.¿
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING AN UROLOGY PROCEDURE, THE TIPS OF TWO OBTURATORS BROKE OFF PRIOR TO INSERTION. NO DEVICE FRAGMENTS FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS 2 OF 2 REPORTS.