MAUDE Adverse Event Report: AESCULAP AG AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL; HIGHSPEED POWER SYSTEMS

Model Number GA513R

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age of device: 7 years, 2 months.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the perforator and air hose.While using the device set at 0.6 mpa and drilling, a part of the hand piece was "burst" and damaged.The reporter did not have further specific details but assumed that another instrument was used to finish the surgery.No patient injury nor harm to medical staff was reported.Additional information was not available.

Manufacturer Narrative

Manufacturing evaluation: investigation - we received the air hose for investigation in a decontaminated condition.The investigation was carried out by the aesculap technical service (ats).The complained product was manufactured in august 2012.A repair or maintenance cannot be found in our database.A label/stamp with "ats1704jpn" can be found on the product which indicates that a maintenance/repair took place directly in japan in april 2017.Therefore, the next maintenance would have been necessary in april 2018.Optically, the product is in a used condition.The air hose burst at the hand piece side.A reconstruction of the burst area is not possible anymore due to missing fragments.Furthermore, damages/chafe marks of erratic appearance could be found.Batch history review - the device history records have been checked for the mentioned lot number and found to be according to the specifications valid at the time of production.Conclusion and root cause - the failure is most likely usage/wear and tear related.Rationale - on the basis of the investigation results, it is most likely that a usage related failure (damage of the air hose) in combination with wear and tear (exceeded maintenance date) led to the burst.A maintenance did not take place since the air hose was distributed.According to the instructions for use (ifu), a maintenance must be executed at least once a year.

• Brand Name: AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8741306
• MDR Text Key: 149492648
• Report Number: 9610612-2019-00429
• 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: 08/14/2019

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: GA513R
• Device Catalogue Number: GA513R
• Device Lot Number: 51871683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Distributor Facility Aware Date: 06/24/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1