METRx® System 9560100Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ENDOSCOPE 9560100 MED REUSABLE · Class 2
All models of METRx System (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic METRx endoscope appears in 663 adverse event reports, with no deaths and 3 injuries. Reports mostly describe cloudy or hazy images, scratched lenses and cracked or broken parts. Reports fell over the last 12 months, to 74 from 345 in the 12 months before, and there are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 667
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 667 adverse event reports that list this exact device (DI 00885074210353), received between Oct 11, 2017 and Sep 28, 2026 — classified as 3 injuries, 664 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (602 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Optical Problem602
- Scratched Material52
- Contamination /Decontamination Problem45
- Break25
- Crack22
- Material Deformation16
- Poor Quality Image14
- Display or Visual Feedback Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions645
- No Known Impact Or Consequence To Patient31
Recent adverse event reports
The 25 most recent of 667 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Scratched Material
Information was received from healthcare provider (HCP) via the multiple sources (manufacturer representative, Service & Repair) regarding an Endoscope used on patient having Spinal therapy. It was reported that there were scratches on the lens. 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 50911084 ↗MalfunctionSep 25, 2026Optical Problem
Information was received from user facility via manufacturing representative regarding a product identified during an event. It was reported that cloudy images, loose couplers and scratches on outer tubes. No patient was involved in this event. No further complications were reported/anticipated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896189 ↗MalfunctionSep 17, 2026Optical Problem
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a product used for spinal therapy. It was reported that after the scope is attached, the surgical field does not display clearly. There were no further complications or symptoms reported regarding the event. Additional information was received via manufacturer representative that the issue was associated with scope.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802884 ↗MalfunctionSep 15, 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 focus adjustment function was defective and image was blurred. 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 50775073 ↗MalfunctionSep 15, 2026Optical Problem
Information was received from a healthcare provider via Manufacturer Representative regarding a device used for Spinal therapy. It was reported that the image was cloudy. The event occurred preoperatively and 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 50774831 ↗MalfunctionAug 27, 2026Break; Optical Problem
Information was received from a healthcare professional regarding endoscopes. It was reported that there is Cloudiness due to lens breakage. 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 50471474 ↗MalfunctionAug 27, 2026Break; Optical Problem
Information was received from a heathcare professional regarding endoscopes. It was reported that there is Cloudiness due to lens br eakage. 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 50471378 ↗MalfunctionAug 13, 2026Optical Problem
Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a device used for Spinal thera py. It was reported that the image was cloudy/hazy. There was no patient symptom reported. There were no further complications reported regarding the event. Additional information was received from the manufacturer representative stating that the event occured pre operatively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231207 ↗MalfunctionAug 11, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205195 ↗MalfunctionAug 5, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140615 ↗MalfunctionJul 31, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100861 ↗MalfunctionJul 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057756 ↗MalfunctionJul 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051995 ↗MalfunctionMay 26, 2026Optical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE FIELD OF VIEW OF ENDOSCOPE WAS NOT CLEAR/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 25273594 ↗MalfunctionMay 20, 2026Optical Problem; Scratched Material
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE REPAIR) REGARDING AN ENDOSCOPE HAVING SPINAL THERAPY. IT WAS REPORTED THAT LENS HAD BLACK SPOTS AND SCRATCHES. 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 25228009 ↗MalfunctionMay 14, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE LENS WAS BROKEN WHEN IT WAS DROPPED DURING THE INSTRUMENT COUNT OPERATION. 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 25175467 ↗MalfunctionMay 12, 2026Optical Problem
INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR MICRO ENDOSCOPIC DISCECTOMY (MED) SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE IMAGE WAS CLOUDY. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE IMAGE APPEARED BLURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25147542 ↗MalfunctionApr 30, 2026Optical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPO RTED THAT THE SCOPE 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 25041034 ↗MalfunctionApr 25, 2026Optical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT CLOUDINESS WAS OBSERVED FOR ENDOSCOPE. 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 24991480 ↗MalfunctionApr 25, 2026Optical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE <(>&<)> REPAIR) REGARDING A ENDO SCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHEN INSTRUMENT WAS INSERTED INTO THE MAIN UNIT, IT BECAME WHITE AND CLOUDY. 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 24991476 ↗MalfunctionApr 24, 2026Optical Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT IMAGE IS CLOUDY. 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 24978502 ↗MalfunctionApr 16, 2026Optical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SERVICE REPAIR) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ENDOSCOPE WAS CLOUDY/NOT CLEAR. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS LUMBAR DISC HERNIATION PRE-OP DIAGNOSIS FOR MICRO ENDOSCOPIC DISCECTOMY (MED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893096 ↗MalfunctionApr 3, 2026Optical Problem
INFORMATION WAS OBTAINED FROM MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE. IT WAS STATED THAT THE VISUAL WAS DIRTY. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS OBTAINED STATING THAT THE PROCEDURE INVOLVED WAS MED (MICROENDOSCOPIC DISCECTOMY) AND THE EVENT CONTEXT WAS POST-OPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774330 ↗MalfunctionApr 1, 2026Crack
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE LENS WAS CRACKED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS MICROENDOSCOPIC DISCECTOMY (MED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755632 ↗MalfunctionApr 1, 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 WAS OUT OF FOCUS. 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 24752796 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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