NA 7210569FRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010658500), received between May 15, 2018 and Jun 21, 2021 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Unstable” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE SPIDER WAS NOT HOLDING PRESSURE DURING AN INSPECTION. THERE WAS A SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037463 ↗
• MalfunctionJun 16, 2021Leak/Splash; Decrease in Pressure; Unstable; Leak/Splash; Decrease in Pressure; Unstable

  IT WAS REPORTED THAT THE SPIDER WAS LEAKING AIR AND WAS NOT HOLDING PRESSURE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011309 ↗
• MalfunctionJun 9, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE RFB POSITIONER SPIDER LIMB WAS NOT HOLDING PRESSURIZING OR POSITION. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968452 ↗
• MalfunctionMay 12, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SPIDER'S LIMB HOSE IS LEAKING. NO PATIENT INVOLVEMENT REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A LOSS OF TRACTION WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812049 ↗
• MalfunctionApr 14, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS SLIPPING/MOVING WHEN UNDER PRESSURE BEFORE A SHOULDER SCOPE. THE PROCEDURE WAS COMPLETED WITH A WORKING SPIDER UNIT. NO PATIENT INJURY, DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663379 ↗
• MalfunctionMar 24, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE SPIDER LIMB POSITIONER WAS NOT HOLDING POSITION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566556 ↗
• MalfunctionFeb 18, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WON'T HOLD THE JOINT, SEALS MIGHT BE DAMAGED. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345511 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE BLACK LEVER TO LOCK SPIDER POSITION BROKE OFF. THE LEVER TO TIGHTEN THE SPIDER MOUNTING CLAMP TO THE SURGICAL TABLE ACCESSORY BAR BROKE OFF AT THE WELD. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319771 ↗
• MalfunctionSep 7, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE SPIDER TENET WAS NOT HOLDING PRESSURE. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10500354 ↗
• MalfunctionAug 6, 2020Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT THE HANDLE OF THE SPIDER LIMB BROKE OFF, WHICH CAUSED THAT THE DEVICE COULD NOT BE USED SINCE THERE IS NO WAY TO SECURE THE POSITION OF THE PATIENT WITHOUT THIS HANDLE. INCIDENT OCCURRED BEFORE THE SHOULDER REPAIR PROCEDURE. THERE WAS NO DELAYS AND A BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10372829 ↗
• MalfunctionAug 4, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SPIDER LIMB WAS NOT LOCKING IN POSITION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10365484 ↗
• MalfunctionJul 16, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE RFB POSITIONER SPIDER LIMB WAS NOT WORKING, AND PRESENTED A LOST OF TRACTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10286508 ↗
• MalfunctionJul 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT RFB POSITIONER SPIDER WAS LEAKING NITROGEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10273400 ↗
• MalfunctionJun 25, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SPIDER POSITIONER LIMB HANDLE WAS BROKEN, IT WAS STUCK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10197042 ↗
• MalfunctionMar 6, 2019Leak/Splash

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, DEVICE WAS LEAKING THEREFORE IT WAS DRIFTING. THERE WAS NO BACK UP DEVICE, NO DELAY AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396711 ↗
• MalfunctionOct 25, 2018Connection Problem

  IT WAS REPORTED THAT THE ROTATION LEVER WILL NOT LOCK. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8007267 ↗
• MalfunctionMay 15, 2018Device Slipped

  IT WAS REPORTED THAT THE DEVICE WAS NOT HOLDING. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7515509 ↗