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

Country of complaint: (b)(6).It was reported that a device burst during surgery, which caused a staff member to suffer from hearing trauma.

Manufacturer Narrative

Investigation: the investigation was carried out by ats.The claimed ga513r was delivered on 02/22/2013.A maintenance or repair of the product is not listed in sap.The device is in a used condition, several signs of wear and tear can be found.The clutch end of the hose is burst and soiled.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.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 usage.Rational: due to the damaged surface of the hose a safe handling can no longer be guaranteed.Most likely the hose has been damaged by a cut or stitch during application.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: 7072583
• MDR Text Key: 93440907
• Report Number: 9610612-2017-00566
• 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: 01/17/2018

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: GA513R
• Device Catalogue Number: GA513R
• Device Lot Number: 51905307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/14/2017
• Device Age: 4 YR
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• 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