MAUDE Adverse Event Report: AESCULAP AG ELAN 4 ELECTRO DISPOSABLE TUBE SET; MOTOR, DRILL, ELECTRIC

Model Number	GA395SU
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should additional relevant information become available as a result of the investigation, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an elan 4 electro disposable tube set (part # ga395su) was to be used during an unknown procedure performed on (b)(6) 2020.According to the complainant, the inlet and outlet for the rinsing hose adapter appeared to be incorrectly assembled.Reportedly, the system pumped air into the flush solution bottle.The device issue was observed prior to the start of the procedure.The complaint device was returned to the manufacturer for evaluation.No patient involvement.Although requested, additional information has not been received.Should further relevant details become available, a supplemental medwatch report will be submitted.The malfunction was filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the tube sets have been analysed visually.To check the tube sets and the condition of assembly, all packages have been opened.The complained failure pattern by the customer could be confirmed.13 tubes out of the 43 were assembled incorrectly.The hose connections was interchanged and assembled the wrong way onto the so called pump segment fixing holder.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that two similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.Specifically, it is assumed that the tube sets are partially assembled incorrectly.Based upon the investigations results a psc was initiated - any actions regarding capa will be adressed with this additional inspection.

• Brand Name: ELAN 4 ELECTRO DISPOSABLE TUBE SET
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11109456
• Report Number: 9610612-2020-00964
• Device Sequence Number: 11665004
• Product Code: HBC
• UDI-Device Identifier: 04046963894559
• UDI-Public: 4046963894559
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: GA395SU
• Device Catalogue Number: GA395SU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1