SILS SILSHOOK36Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884523000627), received between Oct 12, 2017 and Mar 25, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THERMAL BALLOON ABLATION PROCEDURE, THE DEVICE'S HOOK TIP SNAPPED AND DISLODGED INTO PATIENT CAVITY. TO RESOLVE THAT ISSUE THE SURGEON RETRIEVED THE COMPONENT LAPAROSCOPICALLY AND USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572900 ↗
• MalfunctionMay 1, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING BULLECTOMY PROCEDURE, THE DEVICE WAS USED FOR THE RESECTION OF LUNG ADHESION. AS THE PART OF ADHESION WAS VERY STIFF, L HOOK SEEMED TO BE BROKEN. THE TIP PART OF L HOOK WAS IN THE STATUS OF CHIPPING. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8571089 ↗
• MalfunctionJan 16, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE OF TRANSANAL TOTAL MESORECTAL EXCISION, THE STAFF NOTICED THAT THE INSULATION HAD BROKEN, WHEN THE DEVICE WAS ACTUALLY BEING CLEANED. IT WAS REPORTED A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253910 ↗
• MalfunctionNov 19, 2018Device Remains Activated; Device Remains Activated

  ACCORDING TO THE REPORTER, DURING LUNG MOBILIZATION ON A LAPAROSCOPIC VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE HANDLE ON THE DEVICE JAMMED AND WOULD NOT STOP ACTIVATING THE ENERGY, THE SURGEON HAD TO PHYSICALLY OPEN THE HANDLE TO STOP THE ENERGY. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084874 ↗
• MalfunctionNov 19, 2018Device Remains Activated; Difficult or Delayed Activation; Device Remains Activated; Difficult or Delayed Activation

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY LOBECTOMY, WHILE APPROACHING THE LUNG, THE TRIGGER OF THE DEVICE BECAME STUCK AND THE DEVICE WOULD NOT STOP ACTIVATING THE ENERGY. SURGEON HAD TO PHYSICALLY PUSH THE TRIGGER OPEN TO STOP THE ENERGY ACTIVATION. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084577 ↗
• MalfunctionOct 12, 2017Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE FELL APART TOWARDS END OF CASE. THE CASE WAS ABLE TO COMPLETE WITH NO INTERVENTION NEEDED. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945888 ↗