MAUDE Adverse Event Report: AESCULAP AG HUDSON CHUCK F/GB102R/GB169R/GA522R; POWER SYSTEMS

Model Number GB106R

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product hudson chuck f/gb102r/gb169r/ga522r.During burhole surgery (left temporalcraniotomy) when the craniotome blade reached the hematoma, the blade injured the patients dura mater.An additional medical intervention was necessary.The injury was sutured by the surgeon, and , by suturing the injured part, it took extra time in the surgical procedure (not known how long).The procedure was finished and, so far , there has not been any further complications to the patient reported to us.The surgeon stated that the blade injured the dura mater, probably because of the thin skull, but he wants to have the device checked to see if there was any defect.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 400443989_9610612-2019-00661, 400443990_9610612-2019-00662, 400443991_9610612-2019-00664.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00661, (b)(4)_9610612-2019-00662, (b)(4)_9610612-2019-00663, (b)(4)_9610612-2019-00664.Manufacturing site evaluation: the devices are in a used condition.The investigation has been carried out by the aesculap technical service (ats).Te563 spare cutter - (52107655) the complained spare cutter was manufactured in november 2008.The last repair took place in january 2018 due to blunt cutting edges.Optically, the product is in a bad condition.The cutting edges are showing clear damages.Therefore the cutting behaviour is bad.Strong pressure is necessary to cut.Due to the damages of the cutting edges a correct coupling is no longer guaranteed.Gb169r micro line drill (batch 51443690, serial (b)(6)) manufactured in 2007.No failure could be detected at the handpiece.A laser engraving shows "ats1207 jpn" and indicates that the last maintenance was carried-out in july 2012.A further maintenance is therefore recommended.Gb106r hudson chuck no failure could be detected at the hudson chuck.A laser engraving shows "ats1207 jpn" and indicates that the last maintenance was carried-out in july 2012.A further maintenance is therefore recommended.Ga173 micro flexible cable (batch 51515470, serial (b)(6)) the flexible cable was manufactured in november 2018.Optically, the product is in a used condition.A functional test reveals running noises and a worn condition in general.A laser engraving shows "ats1207 jpn" and indicates that the last maintenance was carried-out in july 2012.A further maintenance is therefore recommended.Batch history review - the device history records have been checked for the available lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against any of the above mentioned lot numbers.Conclusion and root cause - the failure is most probably usage / maintenance related.Rationale - refer to investigation.A warning note regarding blunt cutting edges can be found in the instructions for use (ifu): "risk to patient if the blades are damaged; risk of burns to skin and tissue caused by blunt tools".

• Brand Name: HUDSON CHUCK F/GB102R/GB169R/GA522R
• Type of Device: POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9124647
• MDR Text Key: 166156118
• Report Number: 9610612-2019-00663
• Device Sequence Number: 1
• Product Code: HXY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB106R
• Device Catalogue Number: GB106R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention