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 Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).During surgery it was reported that the air hose burst.Two (2) surgical nurses had temporary deafness.After a few hours their hearing returned.

Manufacturer Narrative

Investigation: the device was delivered on the 10th of june 2013.A repair or a maintenance cannot be found in the system.A functional testing is not possible due to the fact that the hose as well as the connections are tight.Its not possible to reconstruct the hose at the burst position.Fragments are missing.A clear and definite conclusion can not be drawn.Most likely a handling failure (kinking of the hose) led to the mentioned burst.Batch history review: the device history files have 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: 6728734
• MDR Text Key: 80569011
• Report Number: 9610612-2017-00359
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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: 51931403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/05/2017
• Device Age: 4 YR
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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