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

Model Number GA506R

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6).During procedure, outer tube burst.A surgeon got hit around eye by a fragment.Some fragments were missing.No injury for patient and the surgeon was reported.

Manufacturer Narrative

Investigation: the investigation has been carried out by the aesculap technical service department (ats).The ga506r has been manufactured in 2010.The last repair was executed at ats (b)(6) in march 2017.It is not possible to determine what was done during the repair.Optically, the tube is in a used condition.The surface of the tube shows scattered mechanical damages and bruises.The o-ring is missing a the motor coupling.A functional test was not possible, due to the fact that the outer tube burst and the inner tube is not connected anymore with the connector nipple.The root cause is most probably attributable to wear and tear as well as handling.A maintenance must take place at least once a year.Batch history review: the device history records have been checked for the above mentioned 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 most probably handling/ wear and tear related.No capa is necessary.

• Brand Name: AIR HOSE 5.0M SCHRADER/AESCULAP SMALL
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7492175
• MDR Text Key: 107567660
• Report Number: 9610612-2018-00194
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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: 51642053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2018
• Device Age: 8 YR
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other