MAUDE Adverse Event Report: AESCULAP AG MICROSPEED UNI PERFORATOR DRIVER; HIGHSPEED POWER SYSTEMS

Model Number GD685

Device Problems Electrical /Electronic Property Problem (1198); Failure to Auto Stop (2938); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

When additional information becomes available a follow up report will be submitted.

Event Description

It was reported the drill would not stop advancing it was reported that during a craniotomy the drill would not stop advancing during use.Per the reporter, the patient was not harmed at all and that there is a thought that the burr (drill bit) used with the device (a non aesculap device) was the issue and not the drill as the same issue had occurred 2 and a half years ago.The surgical staff switched out the entire drill.The incident caused a 15 minute delay.The delay was caused as they surgical staff needed to get a new drill from another room and have it sterilized and then hooked up.The hospital has another loaner device.No additional intervention was required.Additional information has been requested, however, not yet received.

Manufacturer Narrative

The product was received and the complaint was re-opened.Manufacturing evaluation: gd685, serial number (b)(6), batch number 52179241, manufacturing date 12nov2015 investigation - we received the product; the device was in a used condition.The investigation was carried out by aesculap technical service (ats).According to the laser engraving, a maintenance should have taken place in january 2017.The device has been checked and found to be functionally in order.However, loud running noised could be detected, therefore the device has been disassembled.The interior shows strong staining and the ball bearings are damaged.The mentioned failure by the customer could not be confirmed.The device was tested with a trepan drill bit which functioned correctly.Batch history review - the device history records have been checked for the available lot number and found to be according to the specification valid at the time of production.No similar complaints registered against the same lot number.Conclusion - the failure is most likely usage related.Rationale - on the basis of the provided information and the investigation, we do not see a causality between the mentioned failure and our product (perforator driver).It is most likely that the tool itself (trepan drill bit) is associated with the failure pattern.The tool is responsible for the correct release (stop) behaviour.We have no information regarding the used drill bit and whether it is an aesculap product.A capa is not necessary.

• Brand Name: MICROSPEED UNI PERFORATOR DRIVER
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8800347
• MDR Text Key: 152109280
• Report Number: 9610612-2019-00466
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• PMA/PMN Number: K053526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD685
• Device Catalogue Number: GD685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1