MAUDE Adverse Event Report: AESCULAP AG ELAN 4 ELECTRO 1-RING HANDPIECE L7; HIGHSPEED POWER SYSTEMS

Model Number	GA862
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an elan 4 electro 1-ring handpiece l7 (part # ga862) was used during a procedure performed on (b)(6) 2021.According to the complainant, a strange sound occurred.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: optically, the handpiece is in a used but good condition.The investigation has been carried-out by the aesculap technical service (ats).The handpiece was disassembled and inspected according to the corresponding elan 4 checklist.Conclusion: ball bearing broken, tool cannot be clamped.Based on the provided information and after the investigation, it came to a breakage of the ball bearing (b)(6).This led to the complained failure pattern.There is no indication for a manufacturing / product failure.Furthermore, the device history records (dhr) files are inconspicuous.It is possible that the ball bearing broke due to found residues inside the handpiece in combination with an overload situation which might have led to a stronger wear and tear.However, a clear conclusion cannot be drawn.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 no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ELAN 4 ELECTRO 1-RING HANDPIECE L7
• Common Device Name: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11843347
• Report Number: 9610612-2021-00377
• Device Sequence Number: 4545920
• Product Code: HBC
• UDI-Device Identifier: 04046963793982
• UDI-Public: 4046963793982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

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 Model Number: GA862
• Device Catalogue Number: GA862
• Device Lot Number: 52609721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown