Epix Electrosurgical Probe with Smoke Evacuation - L-Hook CW002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915136147), received between Dec 17, 2018 and Dec 17, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 12, 2018Class IITerminated

   Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

   Z-0509-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2018Material Separation; Material Separation

  CER 2018-101133 WAS CREATED FOR DEVICE 1. CER 2018-101134 WAS CREATED FOR DEVICE 2. AT THE BEGINNING OF 2 PROCEDURES, BEFORE THE USAGE, THE INSULATION ON TOP, JUST RIGHT BEFORE THE L, WAS DETACHED FROM THE REST OF THE SHAFT. THE SURGEON REALIZED THE DAMAGE RIGHT AFTER THE SCRUB TECH PASSED THE PROBE. THE SURGEON DECIDED TO KEEP USING THE MATERIAL AND ACTUALLY WAS REALLY HAPPY WITH THE PERFORMANCE OF THE PRODUCT DURING THE WHOLE TATME. THE ENERGY USED WAS CUT 45 AND COAG 50. BOTH SAMPLES WERE DISPOSED AFTER THE USAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172202 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  CER 2018-101133 WAS CREATED FOR DEVICE 1 CER 2018-101134 WAS CREATED FOR DEVICE 2 AT THE BEGINNING OF 2 PROCEDURES, BEFORE THE USAGE, THE INSULATION ON TOP, JUST RIGHT BEFORE THE L, WAS DETACHED FROM THE REST OF THE SHAFT. THE SURGEON REALIZED THE DAMAGE RIGHT AFTER THE SCRUB TECH PASSED THE PROBE. THE SURGEON DECIDED TO KEEP USING THE MATERIAL AND ACTUALLY WAS REALLY HAPPY WITH THE PERFORMANCE OF THE PRODUCT DURING THE WHOLE TATME. THE ENERGY USED WAS CUT 45 AND COAG 50. BOTH SAMPLES WERE DISPOSED AFTER THE USAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172108 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  PROCEDURE PERFORMED: TATME. THE ISOLATION ON THE HOOK HAD COME LOOSE AND COULD BE PUSHED BACK AND FORTH. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172089 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  PROCEDURE PERFORMED: TATME . EVALUATION WITH [ DR] ABOUT NEW GPP+ISB+HOOK. EVERYTHING WENT FINE BUT DURING CLEANING THE TIP OF THE HOOK, TINY PART OF INSULATION JUST RIBBED OFF. I TRY TO CLEAN THE HOOK AS MUCH I COULD AND IT IS NOW IN MY CAR. CLEANING DEPARTMENT DID NOT WANT TO CLEAN IT BEACUSE IT IS SINGLE USE INSTRUMENT AND THEY DID NOT WANT TO KEEP IT IN THEIR DEPARTMENT. WE DECIDED TO TAKE IT WITH US. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS DID OCCUR ASSOCIATED WITH THE COMPLAINT EVENT TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172083 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  PROCEDURE PERFORMED: TATME. ELECTROSURGICAL PROBE WAS USED IN TATME PROCEDURE IN COMBINATION WITH GELPOINT PATH AND ISB DURING A TEST CASE (SOFT LAUNCH) OF THE NEW PRODUCTS (GPP WITH ISB AND NEW EPIX PROBE) IN [CITY] WITH [DR] AND CD BEING PRESENT DURING THE CASE. AFTER HAVING WORKED WITH THE PROBE FOR A WHILE, SUDDENLY THE SURGEON NOTICED SOME INSULATION PARTS OF THE L-HOOK FALLING OFF. PROBE WAS CLEANED THEN AND THE REMAINING PIECES OF INSULATION MATERIAL WERE FULLY REMOVED BY THE SCRUB NURSETHE L-HOOK AND SUCTION FUNCTION WERE BOTH ACTIVATED SEVERAL TIMES AFTER THE INCIDENT HAD HAPPENED. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: PROBE WAS CLEANED THEN AND THE REMAINING PIECES OF INSULATION MATERIAL WERE FULLY REMOVED BY THE SCRUB NURSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172082 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  PROCEDURE PERFORMED: TATME. DURING THE CASE THE SCRUB NURSE NOTICED THE SMALL BLACK RUBBER JUST BEFORE THE L DETACHED (SEE THE PICTURE). THIS INSULATING PART WAS DETACHED FROM ITS BASE, HOWEVER IT COULD BE FIXED BY PUSHING IT TOWARD THE SHAFT WITH TWO FINGERS. THIS ISSUE DIDN'T AFFECT THE EVACUATION PERFORMANCE OR THE MONOPOLAR FEATURES. THE SURGEON DIDN'T EVEN NOTICE THAT. THE CLEANING METHOD WAS WITH A WET GAUZE, NO EXCESSIVE PRESSURE WAS NOTICE DURING THAT PROCEDURE, ALTHOUGH IN THE FIRST PART OF THE PROCEDURE THE HOOK WAS CLEANED MORE FREQUENTLY. INDEED DURING THE MUCOSA INCISION THE MORE ESCHAR WAS NOTICED THAN IN THE MESORECTAL DISSECTION. SETTINGS OF THE MONOPOLAR, 60 CUT. THE GREEN SHEATH HAS BEEN ALWAYS PUT OVER THE L TIP TO PROTECT DURING THE INSERTION OR EXTRACTION FROM THE TROCAR. ALSO I NOTICED THE TIP WAS BENT AND THE GREEN SHEATH COULDN'T COVER THE TIP TILL THE END, SO THE NURSE PUSHED IT BACK IN PLACE AND IT WORKED WELL. I ASKED FOR THE SAMPLE, BUT WHEN THEY WENT TO PUT IN A PLASTIC BAG, I SAW THEY PUT IN A DECONTAMINATING POOL, THEN IT HAS BEEN WASHED. NOT SURE IF THIS AFFECT THE ENGINEERING TEST. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172070 ↗