Integra® Ruggles®-Redmond™ RN6202Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780458906), received between Feb 26, 2022 and Jul 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES (RN6202) WAS "BLUNT AND NOT AS SHARP AS IT SHOULD BE". IT WAS REPORTED THAT THERE WAS AN INCREASE IN SURGERY TIME OF OVER 30 MINUTES, AS THE "DOCTOR HAD TO OPEN HIS OLD SET TO USE" TO FINALIZE THE SURGERY. NO PATIENT INJURY OR DEATH OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378951 ↗
• InjuryFeb 26, 2022Break; Break

  THE FOLLOWING WAS REPORTED VIA MEDWATCH MW5105526: ¿PATIENT UNDERWENT SURGERY FOR REMOVAL OF ACOUSTIC NEUROMA. DURING THE RESECTION OF THE TUMOR, THE TIP OF THE RHOTON DISSECTOR BROKE OFF AND WENT INTO THE SURGICAL FIELD. AFTER A CT DETERMINED THE LOCATION OF THE TIP. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2021 TO REMOVE THE TIP FROM THE BRAIN. SMALL METALLIC FOREIGN BODY IS NOTED INTRACRANIALLY IN THE REGION OF THE RIGHT CEREBELLOPONTINE ANGLE. PATHOLOGY COMMENT AFTER REMOVAL- CONSISTS OF 0.2 CM IN GREATEST DIMENSION FLATTENED SOMEWHAT OVOID PORTION OF THE METALLIC FOREIGN MATERIAL.¿ IT WAS SUBSEQUENTLY REPORTED THAT FOLLOWING THE EVENT, THE SURGEONS INSPECTED THE SURGICAL FIELD AND DID NOT FIND THE BROKEN PIECE. AN INTRA-OPERATIVE X-RAY WAS PERFORMED, AND THE RADIOLOGIST RECOMMENDED A POST-OPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH THEN IDENTIFIED THE MISSING PIECE. ALL PARTS WERE COMPLETELY RECOVERED IN THE 2ND SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY, AND AS OF (B)(6) 2021, THE PATIENT WAS RECOVERING AT HOME DUE TO HER UNDERLYING REASON FOR INITIAL SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13609090 ↗