Arthrex® AR-8850DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867390300), received between Jul 22, 2024 and Sep 11, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026No Display/Image

  On (b)(6) 2026, it was reported by a Sales Representative via email that an AR-8850DS, NanoScopic Release System was reported to have nanoscope faulty. No images can be seen. Surgeon can't see a thing. This occurred on (b)(6) 2026 during a Endoscopic carpal tunnel release Procedure. The case was completed successfully. Procedure had to be done open. There was case involvement.

  Patient problems: Insufficient Information

  MAUDE report 50733331 ↗
• InjurySep 11, 2026No Display/Image

  On 27 August 2026, it was reported by a Sales Representative via email that an AR-8850DS, NanoScopic Release System was reported to have nanoscope faulty. No images can be seen. Surgeon can't see a thing. This occurred on (b)(6) 2026 during a Endoscopic carpal tunnel release Procedure. The case was completed successfully. Procedure had to be done open. There was case involvement.

  Patient problems: Insufficient Information

  MAUDE report 50733284 ↗
• InjurySep 11, 2026No Display/Image

  On (b)(6)2026, it was reported by a Sales Representative via email that an AR-8850DS, NanoScopic Release System was reported to have nanoscope faulty. No images can be seen. Surgeon can't see a thing. This occurred on(b)(6)2026 during a Endoscopic carpal tunnel release Procedure. The case was completed successfully. Procedure had to be done open. There was case involvement.

  Patient problems: Insufficient Information

  MAUDE report 50733241 ↗
• InjurySep 9, 2026Failure to Advance

  It was reported that prior to the minimally invasive carpal tunnel release surgery, it was determined that the NanoNeedle Scope could not be passed down the NanoScopic Release System Centerline. As a result, the planned surgical technique had to be changed, and the patient underwent open surgery instead. The surgery was finished successfully. It was not necessary to do a second surgery.

  Patient problems: Insufficient Information

  MAUDE report 50689066 ↗
• MalfunctionAug 14, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255055 ↗
• MalfunctionAug 14, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254865 ↗
• InjurySep 18, 2025Use of Device Problem; Use of Device Problem

  ON 08/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8850DS NANOSCOPIC RELEASE SYSTEM DIALATOR CUT THE DISTAL PORTION OF TRANSVERSE LIGAMENT MAKING THE VISUAL OF THE SCOPE UNWORKABLE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED BY CONVERTING TO AN OPEN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084741 ↗
• MalfunctionFeb 19, 2025Use of Device Problem; Optical Problem; Use of Device Problem; Optical Problem

  ON 02/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06775875 THAT AN AR-8850DS NANOSCOPIC RELEASE SYSTEM HAD NO LIGHT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412652 ↗
• MalfunctionJan 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8850DS NANOSCOPIC RELEASE SYSTEM PICTURE WAS GOING IN AND OUT WHEN IN USE. THIS OCCURRED DURING USE IN A CASE AND WAS SWAPPED OUT WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216940 ↗
• MalfunctionJan 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6)2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8850DS NANOSCOPIC RELEASE SYSTEM PICTURE WAS GOING IN AND OUT WHEN CONNECTED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211248 ↗
• MalfunctionJan 13, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8850DS NANOSCOPIC RELEASE SYSTEM IS MALFUNCTIONING. THE NANO CENTERLINE CAMERA WOULD NOT SNAP INTO THE HANDPIECE WITH THE BLADE SO THE SURGEON WOULDN¿T SEE THE FULL FIELD OF VIEW HE NEEDED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136488 ↗
• MalfunctionDec 6, 2024Defective Component; Defective Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 12/16/2024: A NEW AR-8850DS NANOSCOPIC RELEASE SYSTEM CENTERLINE WAS OPENED WITH NO ISSUES. THE DATE OF THE PROCEDURE IS UNKNOWN. THE PROCEDURE WAS AN ECTR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864011 ↗
• InjuryJul 22, 2024No Display/Image; No Display/Image

  ON 6/24/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4). THAT AN AR-8850DS NANOSCOPIC RELEASE SYSTEM CENTERLINE WITH NANONEEDLE SCOPE ECTR SYSTEM HAD NO PROJECTED IMAGE ONCE THE SCOPE WAS PLUGGED INTO THE CONSOLE. THE PROCEDURE WAS THEN ABORTED AND NOT COMPLETED, AND AN OPEN SURGICAL PROCEDURE RATHER THAN NANOSCOPIC WAS PERFORMED. THIS WAS DISCOVERED DURING A NANOSCOPIC CTR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/8/2024: THE SURGEON'S DECISION TO PIVOT TO AN OPEN TECHNIQUE CALLED AN "OPEN CTR" CHANGED THE SURGICAL TECHNIQUE. A NON-ARTHREX PRODUCT WAS USED FOR THIS TECHNIQUE. DUE TO THE ISSUE, NO CASE DELAY WAS REPORTED, AND NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR HOSPITALIZATION, AND NO ADDITIONAL SURGERY WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792527 ↗