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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AIR HOSE 5.0M SCHRADER/AESCULAP SMALL; HIGHSPEED POWER SYSTEMS

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AESCULAP AG AIR HOSE 5.0M SCHRADER/AESCULAP SMALL; HIGHSPEED POWER SYSTEMS Back to Search Results
Model Number GA506R
Device Problems Burst Container or Vessel (1074); Unintended Ejection (1234); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).When additional information is received a follow up report will be submitted.
 
Event Description
It was reported the outer tube burst intraoperatively.During a surgical procedure it was reported that the outer tube of the air hose burst.No staff or patient harm.No additional information has been provided.Associated medwatch: 9610612-2019-00306.
 
Manufacturer Narrative
Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: e2014018.Investigation: the investigation has been carried out by the aesculap technical service (ats).The air hose was manufactured and distributed in november 2014.The current maintenance due date on the air hose shows "2018-04".There are no information in the system regarding repair/ maintenance in the past.A labeling "ats1712jp" on the air hose indicates that a repair/maintenance took place at the ats in japan in december 2017.Therefore, a maintenance would have been necessary in december 2018.The outer air hose as well as the inner air hose have busted.No damages can be found at the remaining fragments of the hose, which indicate why it came to the burst.The maintenance date has expired therefore we assume that the root cause can be traced back to wear and tear.Batch history review: the device history records have been checked for the available lot number and found to be according to the specification valid at the time of production.No further complaints registered against the same lot number.Conclusion and root cause: the failure is probably wear and tear/maintenance related.No capa necessary.Associated medwatch: 9610612-2019-00306.
 
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Brand Name
AIR HOSE 5.0M SCHRADER/AESCULAP SMALL
Type of Device
HIGHSPEED POWER SYSTEMS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key8588529
MDR Text Key144969843
Report Number9610612-2019-00305
Device Sequence Number1
Product Code GET
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/27/2019
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 NumberGA506R
Device Catalogue NumberGA506R
Device Lot Number52079373
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Distributor Facility Aware Date06/26/2019
Device Age53 MO
Initial Date Manufacturer Received 04/09/2019
Initial Date FDA Received05/07/2019
Supplement Dates Manufacturer Received06/26/2019
Supplement Dates FDA Received06/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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