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

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.

• 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 Key: 8588529
• MDR Text Key: 144969843
• Report Number: 9610612-2019-00305
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: GA506R
• Device Catalogue Number: GA506R
• Device Lot Number: 52079373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Distributor Facility Aware Date: 06/26/2019
• Device Age: 53 MO
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1