AESCULAP GD670Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04038653347551), received between Nov 30, 2020 and Jan 10, 2022 — classified as 1 death, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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.

• DeathJan 10, 2022Energy Spectrum Incorrect; Energy Spectrum Incorrect

  IT WAS REPORTED TO AESCULAP AG THAT A MICROSPEED UNI CONTROL UNIT W/COOL.UNIT (PART # GD670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE USER HAS HAD ISSUES BEING UNABLE TO DRILL WITH GD670 AND GB304R TOGETHER SINCE LAST WEEK, BUT HAS BEEN ABLE TO DRILL WITH GB304R ATTACHED TO EL4. IN ADDITION, THE S74931, GD675 AND GB757R FREQUENTLY LOSE TORQUE AND STOP DURING CUTTING. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 22, 2021 WHICH REVEALED THE FOLLOWING: "THE CASE OF THE PERFORATOR MALFUNCTION WAS A TEMPORARY SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6)." REPORTEDLY, "IT TOOK TIME TO PIERCE, AND IT TOOK ABOUT 20 MINUTES TO SWITCH FROM MSU TO EL4 AND OPEN THE CRANIOTOMY. THE TIME LOSS WAS NOT SAID TO BE CAUSAL, BUT IT IS TRUE THAT THE PATIENT DIED." A PATIENT DEATH WAS REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4). INVOLVED COMPONENTS GD675 - MICROSPEED UNI XS HIGHSPEED MOTOR - LOT 52181657; GD685 - MICROSPEED UNI PERFORATOR DRIVER - LOT 51673034; GB304R - CRANIAL PERFORATOR 12/15MM HUDSON SHANK - LOT UNKNOWN; GD672 - MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. - LOT 51703

  Patient problems: Insufficient Information

  MAUDE report 13213617 ↗
• MalfunctionDec 31, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO AESCULAP AG THAT A MICROSPEED UNI CONTROL UNIT W/COOL.UNIT (PART # GD670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT THE BRAIN ELECTRIC DRILL WAS USED DURING THE OPERATION, THE ELECTRIC DRILL CIRCUIT SUDDENLY FAILED, RESULTING IN THAT THE ELECTRIC DRILL CANNOT BE USED. THE HAND DRILL WAS USED INSTEAD, WHICH PROLONGED THE OPERATION TIME LED TO BLEEDING. IT WAS CONFIRMED THAT BACKUP HAND PIECE WAS USED AND THERE NO SIGNIFICANT SURGICAL DELAY. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125374 ↗
• InjuryDec 1, 2021Application Program Problem; Application Program Problem

  IT WAS REPORTED TO AESCULAP AG THAT A MICROSPEED UNI CONTROL UNIT W/COOL.UNIT (PART # GD670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, A PATIENT UNDERWENT A FINGER RECONSTRUCTION USING THE MOTOR SYSTEM FOR THE OSTEOTOMY. DURING THE OSTEOTOMY, THE MACHINE GENERATED AN ELEVEN (11) ERROR AND THEN THE HANDLE STOPPED RUNNING. TROUBLESHOOTING WAS PERFORMED ACCORDING TO THE PRODUCT MANUAL, BUT THE FAULT REMAINED. AN ALTERNATIVE MOTOR SYSTEM WAS THEN USED TO CONTINUE THE PROCEDURE. REPORTEDLY, THE FAILURE RESULTED IN THE NEED TO PERFORM A SECOND OSTEOTOMY. THE CUT BONE FAILED TO ACHIEVE THE EFFECT EXPECTED BY THE SURGEON AND RESULTED IN A SECONDARY TRAUMA AND ADDITIONAL DAMAGE TO PATIENT. FURTHERMORE, THE EQUIPMENT HAD TO BE REPLACED HALFWAY THROUGH THE PROCEDURE, WHICH PROLONGED THE SURGERY, INCREASED THE AMOUNT OF BLEEDING AND THE PROBABILITY OF A SURGICAL INFECTION. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Wound Infection

  MAUDE report 12910560 ↗
• InjuryFeb 10, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  UPDATE: INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THERE HAD BEEN NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 11308870 ↗
• MalfunctionFeb 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GD670-MICROSPEED UNI CONTROL UNIT W/COOL.UNIT. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE ON (B)(6) 2020, WHEN THE MEDICAL STAFF CLEANED THE POWER SYSTEM HANDLE AFTER THE OPERATION, IT WAS FOUND THAT THE STEEL BALL IN THE MILLING CUTTER HANDLE FELL OFF AND THE BEARING WAS SERIOUSLY ECTOPIC. CONTACTED THE EQUIPMENT DEPARTMENT FOR MAINTENANCE. THE ENGINEER FOUND THAT THE HANDLE WAS AGING. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267707 ↗
• MalfunctionDec 1, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH MICRO-SPEED UNI CONTROL UNIT (PART # GD670) WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AFTER THE UNIT WAS POWERED ON, THE HANDPIECE WAS FOUND TO BE DAMAGED. REPORTEDLY, THE SPRING DEFORMED AND DETACHED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10925083 ↗
• InjuryNov 30, 2020Device Fell; Device Fell

  IT WAS KNOWN THIS HOSPITAL OUTSOURCED DEVICE MAINTENANCE TO A THIRD PARTY SERVICE PROVIDER. MAINTENANCE STATUS OF THE DEVICE WAS UNKNOWN. FURTHERMORE, CONSUMABLES DURING USE WAS NOT ORIGINAL. AS THIS COMPLAINT WAS NOT INFORMED TO OUR ENGINEER, CONDITION OF ITS USE AND MAINTENANCE WAS NOT ASSESSABLE.

  Patient problems: Aneurysm

  MAUDE report 10924576 ↗