PANOVIEW

Additional Manufacturer Narrative

RWMIC WILL REACH OUT TO THE USER FACILITY AND THE MANUFACTURER TO GATHER ADDITIONAL INFORMATION. UPON RECEIPT OF NEW INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IN (B)(6) 2020, RWMIC RECEIVED THE FOLLOWING COMPLAINT FROM THE USER FACILITY: BOTH SCOPES WERE USED IN SURGERY TODAY AND A CATHETER WAS NOT ABLE TO PASS THROUGH THEM SMOOTHLY. THE DEVICES WILL BE RETURN FOR EVALUATION. THE DEVICES WERE BEING USED ON THE PATIENT WHEN THE ISSUE OCCURRED BUT DID NOT CAUSE ANY INJURY OR ILLNESS TO THE PATIENT OR ANY OTHER PERSONNEL. THE ISSUE DID CAUSE A DELAY IN THE PROCEDURE BUT THE DELAY DID NOT PUT THE PATIENT AT RISK. THERE WAS A SIMILAR BACK UP DEVICE AND THE SCHEDULE PROCEDURE WAS COMPLETED.

Description of Event or Problem

FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION.

Additional Manufacturer Narrative

FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. THE DEVICE WAS RETURNED AND EVALUATION WAS CONDUCTED USING VISUAL AND FUNCTIONAL TESTING. THE REPORTED CONDITION WAS CONFIRMED DURING EVALUATION; CATHETER WAS NOT ABLE TO PASS THROUGH THE SCOPE SMOOTHLY. THE PROBABLE ROOT CAUSE WAS DETERMINED TO BE: THE SCOPE WAS DAMAGED FROM NON-WOLF REPAIR, NON-WOLF PARTS USED. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: H6, H10. CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: B4, B5, D10, F7, G7, H3, H7. DEVICE LABELING WAS REVIEWED FOR PATIENT CODE AND DEVICE CODES, SEE BELOW: PATIENT CODE: NOT APPLICABLE, NO PATIENT PROBLEM WAS REPORTED. DEVICE CODE: IFU WAS REVIEWED: THE IFU CONTAINS THE FOLLOWING NOTES AND INSTRUCTIONS FOR USE: USE THE PRODUCT ONLY IN THE COMBINATIONS AND WITH THE ACCESSORIES AND SPARE PARTS SPECIFIED IN THIS INSTRUCTION MANUAL. USE OTHER COMBINATIONS, ACCESSORIES AND REPLACEMENT PARTS ONLY IF THEY ARE EXPRESSLY INTENDED FOR THE PLANNED APPLICATION AND IF THE PERFORMANCE CHARACTERISTICS AND SAFETY REQUIREMENTS ARE MET. THE PRODUCT MUST NOT BE ALTERED IN ANY WAY. THE IFU CONTAINS THE FOLLOWING WARRANTY AND CUSTOMER SERVICE STATEMENTS: ALL PRODUCTS SHOULD BE RETURNED TO RICHARD WOLF FOR ANY NECESSARY OR DESIRED REPAIR OR PART REPLACEMENT. NO PRODUCT REPAIR OR PART REPLACEMENT SHOULD BE DONE OTHER THAN BY RICHARD WOLF UNLESS THE CARE AND INSTRUCTION MANUAL OR OTHER WRITTEN INFORMATION INDICATES THAT REPAIR OR PART REPLACEMENT IS AUTHORIZED. IF AUTHORIZED, PARTS MUST BE REPLACED ONLY BY PARTS SUPPLIED OR SPECIFIED BY RICHARD WOLF, AND PRODUCT REPAIR AND PART REPLACEMENT MUST BE DONE IN STRICT CONFORMANCE WITH RICHARD WOLF SPECIFICATIONS AND INSTRUCTIONS FOR REPAIR AND PART REPLACEMENT, INCLUDING POST REPLACEMENT TESTING AND RECALIBRATION. FAILURE TO FOLLOW THIS REQUIREMENT IN ANY WAY CAN BE DANGEROUS TO YOU, YOUR PERSONNEL AND YOUR PATIENTS AND VOIDS THE WARRANTY FOR THE PRODUCT REPAIRED OR THE PRODUCT IN WHICH THE PART WAS REPLACED AND IF THE PART WAS SUPPLIED BY RICHARD WOLF, FOR THAT PART. CONTACT RICHARD WOLF IF YOU HAVE ANY QUESTION (1) WHETHER REPLACEMENT OF A PART OR A REPAIR IS AUTHORIZED BY RICHARD WOLF, OR (2) WHETHER YOU HAVE COMPLETE INSTRUCTIONS AND SPECIFICATIONS FOR PART REPLACEMENT OR REPAIR. OUR REPAIR POLICY: DEFECTIVE MERCHANDISE WILL BE REPAIRED OR REPLACED AT NO CHARGE TO THE CUSTOMER, PROVIDED THE CUSTOMER DELIVERS SUCH DEFECTIVE MERCHANDISE PREPAID. ANY REPAIRS, MAINTENANCE OR SERVICING OF RICHARD WOLF MERCHANDISE BY ANYONE OTHER THAN A FACTORY AUTHORIZED REPRESENTATIVE WILL RENDER OUR WARRANTY NULL AND VOID. RW MIC CONSIDERS THIS CASE CLOSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. ATTACHMENT: [GA-D356 USA_1.0 (11-0302).PDF].