TELESCOPE "OES ELITE", 4 MM, 70, HD, AUTOCLAVABLE
Received Jun 23, 2020
Report 9610773-2020-00142 · MDR key 10183628
Device
Generic name
Telescope, Rigid, Endoscopic
Manufacturer
Olympus Winter & Ibe GmbhModel number
WA2T470ACatalog number
WA2T470A
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY PROVIDED ADDITIONAL INFORMATION THAT NO PIECES OF THE DEVICE FELL INTO THE PATIENT.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL EVENT RELATED INFORMATION.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION AND DEVICE HISTORY RECORD (DHR) REVIEW. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. BASED ON THE DAMAGE TO THE DEVICE, OBSERVED DURING THE DEVICE EVALUATION, THE LEGAL MANUFACTURER DETERMINED THE MOST PROBABLE CAUSE FOR THIS ERROR PATTERN IS A DAMAGE AT THE OPTICAL SYSTEM (FOR EXAMPLE, BROKEN LENSES). THE TECHNICAL CAUSE FOR THE REPORTED ISSUE IS LIKELY DUE TO IMPROPER HANDLING BY THE CUSTOMER (E.G., DROP, IMPACT, FALL).
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE REPORTED PROBLEM WAS CONFIRMED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED.
Description of Event or Problem
A USER FACILITY REPORTED TO OLYMPUS A CRACKED ROD LENS AND THAT COMPONENTS BROKE OFF INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE EVENT REPORTED TO OLYMPUS. THE INTENDED PROCEDURE IS UNKNOWN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED.