Section 1 – OCI Reporter



Section 1 – OCI Reporter Information FORMCHECKBOX Primary contact is Sales Rep Name: FORMTEXT ?????1. OCI Report taken by: (First and Last) FORMTEXT ?????2. OCI Title: FORMTEXT ?????3. Awareness Date: (yy/mm/dd) FORMTEXT ?????Section 2 – Customer Information FORMCHECKBOX Primary contact: End User4. Reporter Name: (First and Last) FORMTEXT ?????5. Reporter Title: FORMTEXT ?????6. Department: FORMTEXT ????? FORMCHECKBOX End user same as above 7. End User Name: (First and Last) FORMTEXT ?????8. User Title: FORMTEXT ?????9. Department: FORMTEXT ?????10. Phone: ( FORMTEXT ??? ) FORMTEXT ??? - FORMTEXT ???? ext. FORMTEXT ?????11. Fax: ( FORMTEXT ??? ) FORMTEXT ??? - FORMTEXT ???? 12. Email: FORMTEXT ?????13. Hospital Name: FORMTEXT ?????Street: FORMTEXT ?????City: FORMTEXT ?????Prov: FORMDROPDOWN Postal Code: FORMTEXT ?????Section 3 – Product and Incident Information 14. Device Name: FORMTEXT ?????15. Device Model Number: FORMTEXT ?????16. Serial / Lot No: FORMTEXT ?????17. Quantity: FORMTEXT ????18. Product Status: FORMCHECKBOX Purchased FORMCHECKBOX Demo FORMCHECKBOX Loaner19. Device Usage: FORMCHECKBOX New FORMCHECKBOX reused 1-2x FORMCHECKBOX 5-10x FORMCHECKBOX 10x+20. Occurrence:Date(s) of Event: (yy/mm/dd) FORMTEXT ????? FORMCHECKBOX Upon receipt FORMCHECKBOX Before procedure FORMCHECKBOX During procedure FORMCHECKBOX After procedure FORMCHECKBOX Reprocessing FORMCHECKBOX Repair FORMCHECKBOX Other – explain in 21.21. Describe events leading to concern, troubleshoot, reprocessing details, etc. FORMCHECKBOX Continued on additional page FORMCHECKBOX pictures FORMTEXT ?????22. Name and type of procedure being performed: FORMTEXT ????? FORMCHECKBOX Diagnostic FORMCHECKBOX Therapeutic23. Any Image Loss? FORMCHECKBOX Yes: FORMCHECKBOX Total Loss FORMCHECKBOX Intermittent Loss FORMCHECKBOX Still visible FORMCHECKBOX No FORMCHECKBOX N/A24. Was there death or injury to patient/user? FORMCHECKBOX Yes FORMCHECKBOX No Bleeding: FORMCHECKBOX minor FORMCHECKBOX moderate FORMCHECKBOX severe FORMCHECKBOX N/A25. Was the intended procedure completed? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX N/A26. Did the reported problem impact the outcome of the procedure? Describe: FORMTEXT ????? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX N/A27. Was the same device used to complete the procedure?If no, please list Device Model No. & Serial No. used: FORMTEXT ????? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX N/A28. Was any other equipment replaced during the procedure?If yes, please list Device Model No. & Serial No. used: FORMTEXT ????? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX N/ASection 4 – Product Return Information29. Will the device be sent to OCI for Investigation? FORMCHECKBOX If Yes, please call Customer Service at 1-800-387-0437 for a Return Authorization Number FORMCHECKBOX If No, please explain: FORMTEXT ?????30. Was the device reprocessed according to the manual?(select all that apply) FORMCHECKBOX Cleaned FORMCHECKBOX Disinfected FORMCHECKBOX Sterilized FORMCHECKBOX Single-Use device FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX N/ADescribe CDS materials, equipment, etc.: FORMTEXT ?????31. For single-use devices, confirm that it has been manually disinfected and packaged in a biohazard bag: FORMCHECKBOX YesE-mail form to OCI-Regulatory@ or fax to (905) 886-7469Return the device with form to: Attention QIS, Olympus Canada Inc., 25 Leek Crescent, Richmond Hill, ON L4B 4B3 ................
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