LITe DECOMPRESSIONRecalls & reported problems across all models

We found 4 models of LITe DECOMPRESSION by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between May 10, 2016 and Dec 1, 2023 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

LITe DECOMPRESSION recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 1, 2023Open, Classified

   Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.

   Z-0610-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported LITe DECOMPRESSION problems

LITe DECOMPRESSION models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LITe DECOMPRESSION 48080230

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 recall23 reports
• LITe DECOMPRESSION 48089999

  LIGHT, SURGICAL, FIBEROPTIC
  2 reports
• LITe DECOMPRESSION 48080012

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• LITe DECOMPRESSION 48081805

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent LITe DECOMPRESSION adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A COMPANY REPRESENTATIVE REPORTED THAT THE CLAMP FOR A LITE SNAKE ARM DID NOT FIT ON THE POST IN THE TUBE SET. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246879 ↗
• MalfunctionMar 30, 2022Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Material Deformation; Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE SECURING MECHANISM OF A LITE DECOMPRESSION TUBE SNAKE ARM WAS UNABLE TO BE LOCKED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957336 ↗
• MalfunctionDec 1, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE SECURING MECHANISM OF A LITE DECOMPRESSION TUBE SNAKE ARM IS "CRUSHED" AND WILL NOT HOLD THE TUBE. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911056 ↗
• MalfunctionOct 13, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE SECURING MECHANISM OF THE LITE DECOMPRESSION TUBE SNAKE ARM WOULD NOT CAPTURE THE DECOMPRESSION TUBES AS THE TIP IS CRUSHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626672 ↗
• MalfunctionSep 28, 2021Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TUBE SECURING MECHANISM OF ONE LITE DECOMPRESSION TUBE SNAKE ARM WAS DIFFICULT TO ASSEMBLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540110 ↗
• MalfunctionApr 30, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT THE HINGE ON A DECOMPRESSION TUBE SNAKE ARM WAS DEFORMED AND NOT SECURING PROPERLY. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757432 ↗
• MalfunctionApr 28, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT A LITE DECOMPRESSION SNAKE ARM CLASP WILL NOT TENSION ON THE TUBES INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740650 ↗
• MalfunctionApr 21, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT A LITE DECOMPRESSION SNAKE ARM 'ARM HINGE WAS FOUND TO BE BENT, AND NOT HOLDING TUBE SECURELY' INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703879 ↗
• MalfunctionFeb 23, 2021Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT A LITE DECOMPRESSION SNAKE ARM SECURING MECHANISM WOULD NOT TIGHTEN INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366720 ↗
• MalfunctionFeb 22, 2021Difficult or Delayed Positioning; Mechanical Jam; Difficult or Delayed Positioning; Mechanical Jam

  IT WAS REPORTED THAT A LITE DECOMPRESSION TUBE SNAKE ARM 'WOULD NO LONGER CLAMP ONTO THE TUBE DILATOR' OUTSIDE THE OPERATING ROOM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362634 ↗
• MalfunctionFeb 22, 2021Difficult or Delayed Positioning; Mechanical Problem; Difficult or Delayed Positioning; Mechanical Problem

  IT WAS REPORTED THAT THE LITE DECOMPRESSION TUBE SNAKE ARM CLASP WILL NOT TENSION ON THE TUBES INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357979 ↗
• MalfunctionFeb 22, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE LITE DECOMPRESSION TUBE SNAKE ARM CLASP WILL NOT TENSION ON THE TUBES INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357973 ↗
• MalfunctionNov 24, 2020Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT A LITE DECOMPRESSION TUBE SNAKE ARM KNOB JAMMED INTRA-OPERATIVELY. THE LOCKING CLASP OF THE RETRACTOR ARM WOULD NOT TIGHTEN AND THE ARM WOULD NOT CLASP ONTO DILATOR RETRACTOR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897225 ↗
• MalfunctionAug 21, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN LITE DECOMPRESSION TUBE SNAKE ARM SECURING MECHANISM JAMMED INTRA-OPERATIVELY. THE LOCKING KNOB SEIZED UP AND WOULD BARELY ROTATE. THE DEVICE WILL NOT FULLY RELEASE PRESSURE ON THE SNAKE ARM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10438098 ↗
• MalfunctionMar 11, 2019Mechanical Jam; No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT WHILE TURNING THE HANDLE TO TIGHTEN THE SNAKE ARM, THE ARM LOCKED UP. THIS WAS NOTICED RIGHT BEFORE THE PATIENT ENTERED THE SURGICAL ROOM AND ANOTHER BACKUP INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8409946 ↗

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