MAUDE Adverse Event Report: AESCULAP AG AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL; HIGH SPEED POWER SYSTEMS

Model Number GA513R

Device Problem Burst Container or Vessel (1074)

Patient Problem Hearing Impairment (1881)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6).It was reported that during surgery the air hose burst.The staff and patient experienced hearing trauma.

Manufacturer Narrative

Investigation: the device was delivered on the 19th of january, 2011.A repair took place on the 27th of september, 2016.A detailed failure analysis could not take place.The hose burst approximately 10 cm from the motor.Functionally, the motor, the air plug as well as the hose are in order.At the fractured positions, no mechanical damages (bruises, cuts) can be found.However, fragments are missing.A complete reconstruction is not possible.Most likely, a correct circulation of the exhaust air was not completely possible during use, which led to the burst of the hose.A limitation of the exhaust air can occur due to a incorrect fixation of the hose or due to the kinking of the hose.Batch history review; the device history files for the lot number has been checked and found to be according to the specification valid at the time of production.There is no indication of a maintenance failure.Conclusion and root cause: on the basis of the current investigation results, we assume that most likely a handling failure led to the described failure pattern.However, further investigations will be executed.No capa is necessary.

• Brand Name: AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
• 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: 6800257
• MDR Text Key: 82906865
• Report Number: 9610612-2017-00426
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA513R
• Device Catalogue Number: GA513R
• Device Lot Number: 51714453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/10/2017
• Device Age: 6 YR
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2011
• 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