THE SUBJECT DEVICES WERE RETURNED TO OMSC FOR INVESTIGATION. RETURNED DEVICES WERE ONE MAJ-984 AND TWO MAJ-985S. THERE WAS NO REPORT WHICH MAJ-985 WAS RELATED TO THE PHENOMENON. THERE WERE SCRATCHES AT THE TIPS AND THE MIDDLE POSITIONS OF ALL SUBJECT DEVICES. WE CONSIDER THAT THESE SCRATCHES AT THE MIDDLE WERE LIKELY TO BE CAUSED BY THE SCOPE HAVING TOUCHED TO THE PROBE ACTIVATING OUTPUT. THE TINY SHARDS OF METAL WERE CAUSED WHEN THE SCOPE TOUCHED TO THE PROBE ACTIVATING OUTPUT. IT MIGHT HAVE RELATED TO IMPROPER USER HANDLING. ALMOST ALL OF THE TINY SHARDS OF METAL WILL BE COLLECTED BY IRRIGATION FLUID FLOW. ALSO, OLYMPUS STATES THE APPROPRIATE HANDLING OF THE MAJ-984, MAJ-985 AND THE COUNTER-MEASURES AGAINST THE IRREGULARITY IN THE INSTRUCTION MANUAL. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2017-10041, 8010047-2017-10043.
D
Patient 1
OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS REPORT IS REQUIRED. OMSC WAS INFORMED OF THE FOLLOWING; A CUSTOMER REPORTED THAT ON 2 RECENT OCCASIONS OF NEPHRON-LITHOTRIPSY USING LUS-2 ALONG WITH THE MAJ-984 AND MAJ-895 PROBES, THEY HAVE EXPERIENCED VERY TINY SHARDS OF METAL COMING OFF THE PROBES INTO THE PATIENT. THE LUS-2 & MAJ-984 PROBES ARE BEING USED IN CONJUNCTION WITH A WOLF SHORT NEPHROSCOPE WITH 4MM CHANNEL. THERE WAS NO PATIENT INJURY REPORTED. THIS MDR IS TO ACCOUNT FOR ONE CASE USING THE SUBJECT MAJ-985 (FIRST ONE).
N
Patient 1
THE SUBJECT DEVICES WERE RETURNED TO OMSC FOR INVESTIGATION. RETURNED DEVICES WERE ONE MAJ-984 AND TWO MAJ-985S. THERE WAS NO REPORT WHICH MAJ-985 WAS RELATED TO THE PHENOMENON. THERE WERE SCRATCHES AT THE TIPS AND THE MIDDLE POSITIONS OF ALL SUBJECT DEVICES. WE CONSIDER THAT THESE SCRATCHES AT THE MIDDLE WERE LIKELY TO BE CAUSED BY THE SCOPE HAVING TOUCHED TO THE PROBE ACTIVATING OUTPUT. THE TINY SHARDS OF METAL WERE CAUSED WHEN THE SCOPE TOUCHED TO THE PROBE ACTIVATING OUTPUT. IT MIGHT HAVE RELATED TO IMPROPER USER HANDLING. ALMOST ALL OF THE TINY SHARDS OF METAL WILL BE COLLECTED BY IRRIGATION FLUID FLOW. ALSO, OLYMPUS STATES THE APPROPRIATE HANDLING OF THE MAJ-984, MAJ-985 AND THE COUNTER-MEASURES AGAINST THE IRREGULARITY IN THE INSTRUCTION MANUAL. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2017-10040, 8010047-2017-10041. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2017-10042 TO CORRECT CROSS REFERENCE MFR. REPORT NUMBERS.