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 Loss (1882)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the air hose burst during surgery.Due to this there was temporary hearing loss but the hearing returned after a few hours.

Manufacturer Narrative

Investigation: a detailed failure analysis could not take place.The hose burst centrally.Functionally, the motor, the air plug as well as the hose are in order.A mechanical damage can be found on the burst hose.The bruise most likely caused the burst of the aire hose.A correct circulation of the exhaust air was not possible.Batch history review: the device history files for the material has been checked and found to be according to the specification valid at the time of production.There is no indication of a manufacturing failure.Conclusion and root cause: the mentioned failure is most probably user related.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: 6778758
• MDR Text Key: 82595231
• Report Number: 9610612-2017-00395
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• 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: 51981115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/28/2017
• Device Age: 3 YR
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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