N/A 9560101Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 00673978085456), received between Mar 9, 2017 and Sep 28, 2026 — classified as 2 injuries, 200 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (185 reports).

3 other recalls cover devices cleared under the same FDA submission (K993021); they may or may not involve this specific model.

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 25 most recent of 202 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Optical Problem

  Information was received from user facility via a manufacturer representative regarding an endoscope used for Spinal therapy. It was reported that the inside was no longer visible. There was no patient involvement reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911108 ↗
• MalfunctionSep 25, 2026Optical Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare professional, Service Repair) regarding a En doscope used for Spinal therapy. It was reported that the instrument was not clear(cloudy). The screen went black and it improved when scope was replaced. Event occurred during intra-op and since event was discovered at an early stage, there was not much patient i nvolvement. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894130 ↗
• MalfunctionSep 1, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50540288 ↗
• MalfunctionAug 26, 2026Optical Problem

  Information was received from user facility via a manufacturer representative regarding a device used for spinal therapy. It was rep orted that the endoscope was dark. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the event occurred during intra-op and the preoperative diagnosis for the event w as Lumbar herniation for Micro endoscopic Discectomy and no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50443930 ↗
• MalfunctionAug 17, 2026Contamination /Decontamination Problem; Optical Problem

  Information was received from a manufacturer representative, Service Repair regarding a Endoscope used for Spinal therapy. It was reported that image defect and Internal dirt was observed by visual inspection of the lens. There was no patient involvement reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50271068 ↗
• MalfunctionAug 9, 2026Break; Optical Problem

  Information was received from user facility via a manufacturer representative regarding a endoscope used for Spinal therapy. It was reported that the lens had clouding and breakage. There was no patient involvement reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189280 ↗
• MalfunctionJul 28, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050158 ↗
• MalfunctionApr 23, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE REPAIR) REGARDING A ENDOSCOPE US ED FOR SPINAL THERAPY. IT WAS REPORTED THAT INSPECTION WAS REQUESTED FOR INSTRUMENT DUE TO CLOUDINESS(NOT CLEAR). IT IS STILL UNKNOWN WHETHER THE PATIENT IS INVOLVED OR NOT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968661 ↗
• MalfunctionApr 16, 2026Optical Problem

  INFORMATION OBTAINED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN SPINAL THERAPY. IT WAS STATED THAT THE IMAGE APPEARED CLOUDY. PATIENT INVOLVED IN THIS EVENT DID NOT EXPERIENCE ANY SYMPTOMS. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE INVOLVED WAS MINIMALLY INVASIVE ENDOSCOPIC DISCECTOMY (MED) AND THE EVENT OCCURRED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897348 ↗
• MalfunctionApr 16, 2026Contamination /Decontamination Problem

  INFORMATION RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT BLACK SPOTS WERE SEEN ON IT. THERE WAS NO PATIENT INFORMATION AVAILABLE. THERE WERE NO FURTHER COMPLICATIONS PRESENT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BLACK SPOTS OCCURRED ON THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892474 ↗
• MalfunctionApr 4, 2026Optical Problem; Scratched Material

  INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT IT HAD POOR IMAGE (QUALITY) AND SCRATCHES PRESENT. THERE WERE NO PATIENT SYMPTOMS REPORTED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784873 ↗
• MalfunctionMar 25, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, SERVICE AND REPAIR) REGARDING A DE VICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMAGE APPEARED CLOUDY/NOT CLEAR. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. EVENT HAPPENED DURING INTRA-OP AND DISC HERNIATION WAS THE PRE-OP DIAGNOSIS FOR THIS PROCEDURE FOR WIPE WITH GAUZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686169 ↗
• MalfunctionMar 13, 2026Contamination /Decontamination Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY FOR [PRE-OP DIAGNOSIS]. IT WAS REPORTED THAT THE LENS WERE NOT CLEAR AND CLOUDY. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593644 ↗
• MalfunctionMar 2, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS POOR VISIBILITY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483259 ↗
• MalfunctionFeb 24, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE, SERVICE REPAIR REGARDING AN ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMAGE ABNORMALITY WAS CONFIRMED AND LENS WAS CLOUDY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425621 ↗
• MalfunctionFeb 10, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMAGE CLOUDINESS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE/THERAPY INVOLVED WAS MICROENDOSCOPIC DISCECTOMY. THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301582 ↗
• MalfunctionFeb 3, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING SERVICING. IT WAS REPORTED THAT THE IMAGE QUALITY IS POOR; COMPARED TO PHOTOS AFTER REPAIR, THE COLORS ARE DULL AND NOT VIVID. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247071 ↗
• MalfunctionJan 13, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THERE WAS IMAGE FAILURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053051 ↗
• MalfunctionJan 6, 2026Optical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE REGARDING A SCOPE. IT WAS REPORTED THAT THERE IS IMAGE ABNORMALITY AS LENS IS NOT CLEAR. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972011 ↗
• MalfunctionDec 30, 2025Optical Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT SCOPE IMAGE CLOUDINESS. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924584 ↗
• MalfunctionDec 26, 2025Optical Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE REPAIR) REGARDING AN ENDO SCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCOPE WAS NOT CLEAR. EVENT OCCURRED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895308 ↗
• MalfunctionDec 23, 2025Crack; Product Quality Problem; Optical Problem; Crack; Product Quality Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR (DIS), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING HERNIATED DISC REMOVAL (DISCECTOMY) SPINAL THERAPY FOR HERNIA. IT WAS REPORTED THAT THE IMAGE WAS NOT DISPLAYED CLEARLY, AND IT WAS SUGGESTED THAT CLOUDINESS OR CRACKING MIGHT BE PRESENT. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURING REPRESENTATIVE THAT THE REPORTED EVENT IS SUSPECTED AS MANUFACTURING ISSUE AS IT HAPPENED DURING INITIAL USAGE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874830 ↗
• MalfunctionDec 22, 2025Optical Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM THE MULTIPLE SOURCES (HEALTHCARE PROVIDER (HCP), SERVICE REPAIR) VIA A MANUFACTURER REPRESENTATIVE REGARDING A ENDOSCOPE USED ON PATIENT HAVING MICRO ENDOSCOPIC DISCECTOMY (MED) THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WAS CLOUDY AND IT WAS DIFFICULT TO SEE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864468 ↗
• MalfunctionDec 10, 2025Optical Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT IMAGE ABNORMALITY, LENS IS SLIGHTLY CLOUDY AND THE SHAFT HAS A DENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765793 ↗
• MalfunctionDec 8, 2025Optical Problem; Optical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMAGE PRODUCED APPEARS BLURRY (POOR IMAGE QUALITY). THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993021. One submission often covers many models, so check the product and lot details in each record.

• Z-0991-05 · Jun 20, 2005 · Terminated
  Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
• Z-0992-05 · Jun 20, 2005 · Terminated
  Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
• Z-0993-05 · Jun 20, 2005 · Terminated
  Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.