MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT; HIGH SPEED POWER SYSTEMS

Model Number GB109

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that during an osteotomy surgery, there was a popping noise, and black oil came out of the proximal tip of the hand piece.The surgeon stopped the procedure.The patient was burned at the commissure of the labial.Component in use listed as concomitant device is: gb109 / micro-line straight hdpc 1:1 round shaft.Gd672 / microspeed uni motor cable f/foot ctrl.Gd678 / microspeed uni micro 150 motor.Gd670 / microspeed uni control unit w/cool.Unit.

Manufacturer Narrative

Investigation: gb109 - 400309978: the hand piece was build in 2013 and never sent in for maintenance.The device is without function and can not be mounted to the engine because the connection part is damaged.Most likely the hand piece was not mounted correctly to the engine several times.Thus the hand piece turned around when starting the engine and damaged the surface inside the connection part.The collet is dirty, rusty and can no longer be opened.The front bearing is broken.In the whole inner room residues are recognizable.The spray nozzle is bent, deformed and torn.A repair is not possible.Gd672 - 400309979: the cable was build in 2010 and never sent in for maintenance.The insulation is porous and has become shorter in the course of the years due to wear and tear.Despite the damage, the cable passed the insulation test but must be replaced for safety reasons.On the housing (gd672401) and flaps (gd673420) rust can be recognized.Gd678 - 400309980: the engine was build at 20.01.2014 and never sent in for maintenance.As already mentioned at the hand piece, the surface is damaged due to incorrect mounted counter part.In the inner room residues and rust, due to an inadequate maintenance, can be found.The stator is swollen and has to be exchanged.This can also be attributed to the inadequate maintenance.Gd670 - 400309981: the product is not available for investigation.Batch history review: a review of the device quality and manufacturing history records was not possible because the device is a purchased part.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient maintenance of the device.Corrective action: according to sop sa-de13-m-4-2-01-010 a capa is not necessary.

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5908689
• MDR Text Key: 53277890
• Report Number: 2916714-2016-00663
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB109
• Device Catalogue Number: GB109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/02/2016
• Device Age: 3 YR
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other