MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM; DRILL

Model Number GD450M

Device Problems Mechanical Problem (1384); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

During an operation a drill was used on one side of the mouth, when it was being used on the other side it was reported that the drill got very hot and left a small burn on the inside of the patients cheek.The consultant using the equipment noted the problem right away and stopped using the drill immediately.Another system was substituted and the case was concluded successfully.No blood loss reported; however, a small burn was noted on the inside of the cheek/ lip which was examined by a dermatologist and was treated with an ointment.Concomitant medical products: ga835, elan ec motor fwd/rev w/irrig, unit, serial no (b)(4); ga176, micro flexible cable 1.8m, serial no (b)(6); le-120-30-a, micro drill strong nozzle short; ga188, foot control w/pedal and two buttons, serial no (b)(4).

Manufacturer Narrative

(b)(4).Correction: initial report indicated issue is adverse event; however, issue is also related to product problem.

Manufacturer Narrative

Investigation: the investigation and the pictorial documentation has been carried out by aesculap technical services (ats).Gd450m: afunctional test was only possible with loud running noises from the ball bearings.Furthermore, the ball bearings are running roughly.The distal end of the device is worn, the ball bearing in the tip is completely missing.Damages and corrosion at the outer and inner surface, as well as on the collet and all the ball bearings can be found.Last documented maintenance in ats: 09.06.2014.Le-120-30-a: the distal end of the spray nozzle is damaged.Ga835:no deviation could be found after a 4 hour functional test.The lever is bent, most likely caused by a drop or impact.Ga176: the flexible shaft is kinked, resulting in high vibrations during the functional test.Furthermore, corrosion, especially at the connection parts of the shaft, can be found.Due to the age of the device and the protection hose has shrunk by about 15mm and the release torque of the clutch has significantly decreased.Last documented maintenance in ats: 15.04.2016 ga188: no deviation could be found after a functional test.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 overload use and to an insufficient maintenance/reprocessing of the devices.Rationale: the breakage of the ball bearing was most likely caused by an insufficient reprocessing.Due to corrosion caused by an insufficient drying of the device, a wear of the ball bearings can not be excluded.According to the ifu, prior to sterilization the device must be oiled.The kink of the flexible shaft was most likely caused by an overload situation during handling or reprocessing.No capa is necessary.

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
• Type of Device: DRILL
• 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: 7916574
• MDR Text Key: 121988236
• Report Number: 9610612-2018-00448
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GD450M
• Device Catalogue Number: GD450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/21/2018
• Device Age: 139 MO
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other