SILS SILSCLINCH36Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884523000580), received between Sep 15, 2016 and Jun 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2017Break; Break

  ACCORDING TO REPORTER DURING A LAP HYSTERECTOMY PROCEDURE THE HANDPIECE WAS VISIBLY BROKEN WHEN OPENED FROM PACKAGING AND UNABLE TO BE USED. NO ADDITIONAL OPERATING TIME. NO ADDITIONAL BLOOD LOSS. NO ADVERSE EFFECT TO PATIENT. NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS, OPENED UP ANOTHER HAND PIECE AND THERE WAS NO ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6633547 ↗
• MalfunctionSep 15, 2016Grounding Malfunction; Grounding Malfunction

  ACCORDING TO THE REPORTER, DURING THE SILS APPENDECTOMY, THE DEVICE GROUNDED ON THE PRE-UMBILICAL SKIN AND CAUSED A SMALL BURN AT THE SITE WHERE THEY ALL TOUCH. THE SILS DEVICE INSULATION WAS NOT DURABLE ENOUGH TO SUPPORT OTHER INSTRUMENTS RUBBING AGAINST IT AT THE SINGLE INSERTION ACCESS POINT. THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. A WOUND DRESSING (GAUZE) WAS PLACED ON THE PATIENT BUT THAT WAS PER NORMAL PROCEDURE. THERE WAS MINOR TISSUE DAMAGE DUE TO THE BURN.

  Patient problems: Burn(s); Tissue Damage

  MAUDE report 5952405 ↗