MAUDE Adverse Event Report: AESCULAP AG AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE; HIGH SPEED POWER SYSTEMS

Model Number GA466R

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It should be noted that complaint information was received 07/07/2016; information regarding blast injury was not received until 10/24/2016.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that 5 people from the operation team were injured when the air hose burst.

Manufacturer Narrative

Investigation: the investigation was carried out by the aesculap technical service department (ats).It has been ascertained, that an old version of the hose was used.This hose was prone to flaws which could lead to a burst.Therefore this hose has been changed via the internal change request: (b)(4).Batch history review: the device history files have been checked for the available lot number and found to be according to the specification, valid at the time of production.Conclusion and root cause: this failure occurred most likely due to design error.Corrective action: a change has been initiated to eliminate the failure, see change.(b)(4).

• Brand Name: AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE
• 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: 6062021
• MDR Text Key: 59018231
• Report Number: 2916714-2016-00936
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GA466R
• Device Catalogue Number: GA466R
• Device Lot Number: 51977098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/25/2016
• Device Age: 3 YR
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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