NA 72200617SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010578884), received between Jun 3, 2017 and Apr 19, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2026Overheating of Device

  IT WAS REPORTED THAT A SVC REPL, MDU, NON-HAND CNTL, ELITE WAS OVERHEATING. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921193 ↗
• MalfunctionMar 9, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT A SVC REPL, MDU, NON-HAND CNTL, ELITE WAS OVERHEATING AND IT HAD A NOISE ENGINE. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551757 ↗
• MalfunctionDec 31, 2025Overheating of Device; Activation Failure; Overheating of Device; Activation Failure

  IT WAS REPORTED THAT THE SVC REPL, MDU, NON-HAND CNTL, ELITE CABLE WAS OVERHEATING, AND IT DIDN'T TURN. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933766 ↗
• MalfunctionApr 14, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MDU IS GETTING HOT, OVERHEATING. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667266 ↗
• MalfunctionJul 24, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE MOTOR DRIVE UNIT WAS NOT WORKING. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. A PRELIMINARY ANALYSIS PERFORMED BY THE MANUFACTURER REVEALED A BLADE STALL ERROR, WHICH IS A REPORTABLE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10321057 ↗
• MalfunctionNov 15, 2017Temperature Problem

  IT WAS REPORTED THAT THE MDU GETS HOT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7034838 ↗
• MalfunctionJun 3, 2017Electrical Shorting

  SHORTING OUT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6610225 ↗