CONMED AES-90SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10653405006473), received between Jul 18, 2019 and Jul 29, 2026 — classified as 14 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (47 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073674 ↗
• MalfunctionMar 10, 2026Self-Activation or Keying

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND ¿SELF-ACTIVATION OF THE PRODUCT" OCCURRED¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559372 ↗
• MalfunctionMar 10, 2026Self-Activation or Keying

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND ¿SELF-ACTIVATION OF THE PRODUCT" OCCURRED¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559371 ↗
• MalfunctionFeb 10, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE AES-90SN ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM, DEVICE WAS BEING USED ON (B)(6) 2026 DURING A SHOULDER ARTHROSCOPY PROCEDURE WHEN IT WAS REPORTED ¿TIP OF AES-90 BROKE OFF DURING SHOULDER ARTHROSCOPY, USED ARTHROSCOPIC GRABBER TO RETRIEVE TIP.¿. THE PROCEDURE WAS COMPLETED WITH THE SAME ALTERNATE DEVICE AND A 5-MINUTE DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿FINE¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303926 ↗
• MalfunctionDec 29, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF MEDSUN REPORT NO. (B)(4), RECEIVED ON 17DEC2025. A SEARCH OF THE COMPLAINT SYSTEM HAS FOUND NO COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM. THIS WAS REPORTED AS A PRODUCT PROBLEM NOT AN ADVERSE EVENT. THE REPORT STATES THAT ON AN UNKNOWN DATE IN (B)(6) 2025, THE ¿TIP OF ARTHROSCOPIC PROBE HIT THE CANNULA AND POPPED OFF, WHEN WE TOOK THE PROBE OUT WE NOTICED THE PIECE WAS MISSING AND WAS ABLE TO GO BACK IN AND RETRIEVE THE TIP IN IT'S ENTIRETY. CASE FINISHED WITHOUT COMPLICATIONS.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905831 ↗
• MalfunctionMay 8, 2025Self-Activation or Keying; Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AES-90SN ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM WAS BEING USED ON AN UNKNOWN DATE AND "WHEN THE HANDLE IS CONNECTED TO THE GENERATOR, THE ELECTRODE STARTS WORKING SPONTANEOUSLY, THEN THE YELLOW BUTTON DOES NOT WORK WHEN PRESSED, BUT ONLY WORKS WHEN PRESSED VERY HARD CLOSER TO THE DISTAL PART OF THE HANDLE.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE ¿JUST NEEDLES AND THREADS¿. A GOOD FAITH ATTEMPT WAS COMPLETED; HOWEVER, NO REPLY HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985182 ↗
• InjuryApr 29, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, AES-90SN ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM WAS BEING USED ON (B)(6) 2025 AND "DURING HIP ARTHROSCOPY, 2 FOREIGN BODIES WERE NOTED ON X-RAY. ONE OF THE THREADS WAS REMOVED - 1/3 OF THE METAL TIP OF THE VAPORIZER. THE OTHER COULD NOT BE LOCATED ARTHROSCOPICALLY - IT WAS LEFT IN THE TISSUES. DAMAGE TO 2/3 OF THE VAPORIZER TIP WAS FOUND, AND IT WAS DISPOSED OF.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS A 45 MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT RETAINING A FRAGMENT OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21925349 ↗
• MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND ¿THE COMBUSTION FLANGE DETACHED FROM THE TIP OF THE VAPORIZER DURING USE IN THE PATIENT'S HIP JOINT.¿. THE PATIENT WAS NOT INJURED. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. IT IS UNKNOWN WHETHER ANY FRAGMENT FELL INTO THE SURGICAL SITE OR WAS RETRIEVED. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO INJURY, ALTHOUGH NOT REPORTED, OF A POTENTIAL RETAINED FOREIGN BODY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445728 ↗
• InjuryFeb 11, 2025Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN AN ARTHROSCOPIC LEFT SHOULDER CUFF REPAIR PROCEDURE ON (B)(6) 2025, AND ¿DURING ACROMIAL CLEANING (ARTHROSCOPY), BREAKAGE OF A METAL PIECE 3 MM PIECE OF METAL FROM THE ELECTROCOAGULATION PROBE LODGED IN THE PATIENT'S DELTOID MUSCLE (SEEN IN THE INTRAOPERATIVE X-RAY). NO CONFLICT WITH ADJACENT STRUCTURES, SO NOT REMOVED. PROBE CHANGED." THE PROCEDURE WAS COMPLETED WITH "ANOTHER PROBE" AND A DELAY OF 1 HOUR. FURTHER DETAILS HAVE BEEN REQUESTED BUT HAVE NOT BEEN MADE AVAILABLE TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21355983 ↗
• MalfunctionJan 31, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE AES-90SN ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, WAS BEING USED ON (B)(6) 2024 AND ¿WHILE USING THE EDGE PROBE, THE PROBE TIP BROKE OFF, AND THE DETACHED TIP WAS RETRIEVED WITH A GRASPER.¿. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283713 ↗
• MalfunctionJan 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2024, AND ¿WHILE USING THE EDGE PROBE, THE PROBE TIP BROKE OFF, AND THE DETACHED TIP WAS RETRIEVED WITH A GRASPER.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE AND A DELAY OF 10 MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272869 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN AN ARTHROSCOPY PROCEDURE, AND ¿AFTER A FEW MINUTES AFTER STARTING THE SURGERY, IT WAS OBSERVED THAT THE RADIOFREQUENCY TIP WAS NOT WORKING CORRECTLY, AS IT COAGULATED VERY INSUFFICIENTLY. THE CONSOLE WAS CHECKED, AND THE PROBLEM WAS RULED OUT. WHEN CHECKING THE RADIOFREQUENCY TIP, IT WAS FOUND THAT IT DID NOT HAVE THE PLATE. THIS INCIDENT CAUSED GREAT ANNOYANCE TO THE SURGEON, WHO REQUESTED TO REPORT THE INCIDENT.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE, AND THERE WAS REPORTEDLY NO IMPACT TO THE PATIENT OR USER. FURTHER ASSESSMENT FOUND THE INCIDENT OCCURRED ON (B)(6) 2024, AND "NO FRAGMENT FELL INTO THE PATIENT SURGICAL SITE. SURGEON MANAGED TO TAKE THE AES-90SN OUT WITHOUT CAUSING ANY PROBLEM TO THE PATIENT NOR THE SURGICAL SITE.¿ THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. ALTHOUGH FOUND DURING THE PROCEDURE, IT WAS NOT CLARIFIED WHETHER DETACHMENT OF THE PLATE OCCURRED BEFORE OR DURING SURGERY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251272 ↗
• MalfunctionJan 27, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION WAS BEING USED ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿WHILE USING THE EDGE PROBE, THE PROBE TIP BROKE OFF, AND THE DETACHED TIP WAS RETRIEVED WITH A GRASPER.¿. THE PROCEDURE WAS COMPLETED WITH A 15-MINUTE DELAY AND THE SAME ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240439 ↗
• MalfunctionNov 20, 2024Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM DEVICE WAS USED IN A HIP INSPECTION PROCEDURE ON 31OCT24, AND ¿THE BURNING PART OF THE TIP OF THE EDGE ASCOPIC 90° PROBE W. SUCTION CAME OFF DURING USE, AND IT HAD TO BE LOCATED IN THE PATIENT'S JOINT, WHICH CAUSED ADDITIONAL TIME FOR THE OPERATION AND A POSSIBLE DANGER FOR THE PATIENT.". THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND A DELAY OF ¿ABOUT 30 MINUTES¿. FURTHER ASSESSMENT FOUND THAT "THE PIECES WERE REMOVED. THE PATIENT DID NOT NEED ADDITIONAL TREATMENT BECAUSE OF THIS. PATIENT STATUS IS NORMAL". THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735448 ↗
• InjuryOct 23, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM WAS BEING USED ON (B)(6) 2024 DURING A ROTATOR CUFF REPAIR AND ¿WE HAD A WAND BREAK OFF INTO A SHOULDER. UNABLE TO FIND PIECE IN SHOULDER¿. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT "WE HAD TO BRING IN A C ARM FOR X-RAY AND WAS NEVER ABLE TO LOCATE THE METAL PIECE.". THE WAND WAS BEING USED TO ABLATE TISSUE AT THE TIME OF THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD". IT IS UNKNOWN IF A 2ND SURGERY WILL BE SCHEDULED TO REMOVE THE FRAGMENT. THERE WAS NO PROLONGED HOSPITALIZATION FOR THE PATIENT. THERE WAS A 45 MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF DEVICE FRAGMENTATION LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20515805 ↗
• MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM WAS BEING USED ON (B)(6) 2024 AND ¿THE TIP OF THE EDGE PROBE ON THE DISTAL END BROKE OFF IN THE PATIENT¿S SHOULDER AND IS NOW IN THE SHOULDER JOINT. X-RAYS ARE BEING TAKEN TO SEE IF THEY CAN GET THE TIP OUT OF THE SHOULDER JOINT¿. AN ALTERNATE NON-CONMED DEVICE WAS USED. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE SURGEON WAS ABLE TO RETRIEVE THE TIP OUT OF THE JOINT. NO PATIENT HARM." THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368932 ↗
• InjurySep 23, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, AES-90SN, ARTHROSCOPIC ENERGY 90° PROBE WITH SUCTION, 13 CM, WAS BEING USED DURING A RIGHT SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿DURING A SHOULDER ARTHROSCOPY PROCEDURE DONE BY (DOCTOR AT FACILITY) ON (B)(6) 2024, THE TIP OF THE EDGE PROBE BROKE OFF. HE WAS UNABLE TO LOCATE THE TIP DURING THE ARTHROSCOPY PROCEDURE AND X-RAY IMAGING WAS REQUIRED TO LOCATE THE TIP OF THE EDGE. AN EXTRA INCISION WAS NECESSARY TO EXTRACT THE TIP.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE CAUSING A 40-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF EXTRA INCISION REQUIRED TO REMOVE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277693 ↗
• InjuryAug 21, 2024Material Separation; Material Separation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN WAS BEING USED ON (B)(6) 2024 DURING AN LEFT SHOULDER ARTHROSCOPY - ROTATOR CUFF REPAIR W/ BICEPS TENODESIS PROCEDURE WHEN IT WAS REPORTED ¿CERAMIC DISC OF THE AES-90SN DISLODGED FROM THE PROBE. CONTINUED CASE AND OPENED A SECOND AES-90SN - SURGEON WAS ADVISED BY MANAGEMENT AND REP THAT THE CERAMIC DISC SHOULD BE REMOVED. X-RAY WAS BROUGHT IN TO LOCATE THE DISC AT THE END OF THE CASE. DISC WAS LOCATED IN THE PATIENTS LEFT DELTOID. SURGEON DECIDED THAT LEAVING THE DISC IN THE DELTOID WOULD CAUSE LESS DAMAGE THAN HIM TRYING TO RETRIEVE. PATIENT WAS CLOSED WITH THE DISC STILL IN DELTOID.¿. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY AND THE USE OF THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE FOREIGN BODY LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20014155 ↗
• MalfunctionJun 6, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN WAS BEING USED ON (B)(6) 2024 DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED ¿TUNGSTEN TIP LOST OFF OF AES-90SN WAND. IT WAS NOT CLEAR HOW THIS HAPPENED OR WHERE THE METAL TIP WENT. X-RAY WAS TAKEN TO MAKE SURE THE METAL TIP DID NOT COME OFF IN THE PATIENT'S SHOULDER. NO TRACES OF METAL WERE SEEN ON THE PATIENT'S X-RAY. THE FAULTY AES-90SN PROBE WAS DISCARDED AND A NEW ONE WAS OPENED. THE CASE CONTINUED WITH NO OTHER DISRUPTIONS. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿IT IS UNKNOWN IF THE TIP FELL INTO THE SURGICAL SITE. HOWEVER, NO TRACES OF METAL WERE SEEN ON THE PATIENT'S X-RAY. THE ITEM WAS USED DURING SURGERY AND DISPOSED OF.¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477434 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN WAS BEING USED ON (B)(6) 2024 DURING A SHOULDER ARTHROSCOPY AND ¿DR. WOULD LIKE TO FILE A COMPLAINT THAT OCCURRED THIS PAST SATURDAY DURING HIS SHOULDER ARTHROSCOPY CASE. FACEPLATE OF AES-90SN FELL OFF INSIDE THE PATIENT AND DR. HAD TO TAKE IT OUT. LUCKILY PATIENT WAS NOT HARMED. I ALSO HAVE THE DEFECTIVE PRODUCT IN MY OFFICE IF NEEDED TO TAKE FOR EVALUATION.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111884 ↗
• MalfunctionMar 12, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN WAS BEING USED DURING A SPINAL ARTHRODESIS PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿TIP OF WAND FELL OFF DURING SURGERY.¿ FURTHER ASSESSMENT FOUND THAT "FRAGMENT (HEAD OF THE WAND) FELL OFF IN SURGERY, RETRIEVED USING BACK TABLE GRASPERS.¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿PATIENT NORMAL STATUS POST SURGERY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884434 ↗
• MalfunctionMar 12, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN WAS BEING USED DURING A SPINAL ARTHRODESIS PROCEDURE ON (B)(6) 24 DATE WHEN IT WAS REPORTED ¿TIP OF WAND FELL OFF DURING SURGERY.¿. FURTHER ASSESSMENT FOUND THAT "FRAGMENT (HEAD OF THE WAND) FELL OFF IN SURGERY, RETRIEVED USING BACK TABLE GRASPERS.¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿PATIENT STATUS NORMAL POST SURGERY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884432 ↗
• MalfunctionMar 7, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN, WAS BEING USED DURING A SHOULDER ARTHROSCOPY, ROTATOR CUFF REPAIR PROCEDURE ON 6FEB24 WHEN IT WAS REPORTED, ¿PIECE OF ENERGY PROBE BROKE OFF IN PATIENT DURING SHOULDER ARTHROSCOPY. REMOVED METAL PIECE FROM PATIENT, CONFIRMED WITH X-RAY.¿. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE CAUSING A 30-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855014 ↗
• InjuryFeb 21, 2024Material Fragmentation; Material Fragmentation

  UPDATE: PER ASSESSMENT RECEIVED ON 5MAR24 THE PROCEDURE WAS COMPLETED AND THE FRAGMENT "DID NOT FALL IN AS THE WAND WAS INSIDE THE PATIENT, IT COULD NOT BE RETRIEVED AS IT COULD NOT BE LOCATED AFTER WASHING AWAY IN SURGICAL FLUID.". THE PATIENT'S CURRENT STATUS WAS REPORTED AS "ROUTINE RECOVERY AT PRESENT". THERE WAS NO PROLONGED HOSPITALIZATION FOR THE PATIENT. THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN WAS BEING USED ON AN UNKNOWN DATE DURING A ROTATOR CUFF REPAIR AND THE ¿TUNGSTEN TIP CAUGHT ON TISSUE AND PULLED OFF THE WAND HEAD. QUARTER OF THE TUNGSTEN TIP BROKE OFF AND IS POSSIBLY STILL IN SITU.¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE ¿REPLACEMENT CART¿. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FRAGMENTATION LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18746810 ↗
• MalfunctionFeb 15, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE AES-90SN, AES-90SN PROBE ASSY,SUCT,SIN DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON APPROXIMATELY ON (B)(6) 2024, AND THE ¿EDGE WAND FACEPLATE DISLOCATED FROM THE PROBE AND HAD TO BE RETRIEVED OUT OF PATIENT - NEEDED TO USE X-RAY TO LOCATE¿. THERE WAS A 15-20 MINUTE DELAY TO THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712824 ↗