MICROTEK 1 (UDI 00748426117581)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00748426117581), received between May 18, 2022 and Jun 3, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DRAPE CRACKED AT THE MOTOR MOUNT. THERE WAS NO PATIENT IMPACT AND PATIENT INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594370 ↗
• MalfunctionJun 2, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE DRAPE ON BOTH THE OUTER AND INNER PACKAGING. THE TEAR WAS NOTICED PRIOR TO THE MEDICAL PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO PATIENT INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14574711 ↗
• MalfunctionJun 2, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE DRAPE ON BOTH THE OUTER AND INNER PACKAGING. THE TEAR WAS NOTICED PRIOR TO THE MEDICAL PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO PATIENT INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14573792 ↗
• MalfunctionMay 31, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DRAPE WAS TORN DURING SURGERY. THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549063 ↗
• MalfunctionMay 31, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORT THAT THE DRAPE WAS PUNCTURED, WHICH WAS NOTICED WHEN THE BOX WAS OPENED. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549055 ↗
• MalfunctionMay 31, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING SET UP, SMALL TEARS WERE NOTICED IN THE DRAPE. THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549054 ↗
• MalfunctionMay 31, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DRAPE WAS TORN, WHICH WAS NOTICED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT IMPACT AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549044 ↗
• MalfunctionMay 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DRAPE WAS ATTACHED TO ITSELF AND TORN. THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462538 ↗
• MalfunctionMay 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BEFORE THE PROCEDURE, IT WAS NOTICED THAT THE DRAPE WAS TORN. THERE WAS NO PATIENT IMPACT AND NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462299 ↗
• MalfunctionMay 20, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, ONE OF THE VELCRO STRAPS WOULD NOT DETACH SO THE MICS CABLE COULD NOT BE COVERED WITH THE DRAPE. THERE WAS NO IMPACT TO THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461966 ↗
• MalfunctionMay 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE MAKO DRAPE. THERE WAS NO IMPACT TO THE PATIENT AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454584 ↗
• MalfunctionMay 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE DRAPE WHICH A NURSE NOTICED DURING PREPARATION FOR SURGERY. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454090 ↗
• MalfunctionMay 20, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A DEFECT IN THE STERILE FILM OF THE ROBOTIC DRAPE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453961 ↗
• MalfunctionMay 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE PROBLEMS WITH TWO ROBOTIC DRAPES FROM THE SAME LOT. ONE DRAPE HAD A HOLE. THE SECOND DRAPE FOLDING WAS NOT DONE AS USUAL AND THE BASE ARRAY FELL OFF DURING UNPACKAGING. BOTH PROBLEMS WERE NOTICED BEFORE THE MEDICAL PROCEDURE AND THERE WAS NO IMPACT TO THE PATIENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453396 ↗
• MalfunctionMay 19, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE MAKO DRAPE RIPPED DURING COVERAGE, PRIOR TO THE MEDICAL PROCEDURE. IT WAS REPORTED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435177 ↗
• MalfunctionMay 18, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PREPARATION FOR A MAKO TKA, THE NURSE NOTICED A TORN DRAPE. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429613 ↗