MAUDE Adverse Event Report: AESCULAP AG ELAN 4 AIR MOTOR HOSE 5M W/HAND CONTROL; HIGHSPEED POWER SYSTEMS

Model Number	GA707R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with ga707r - elan 4 air motor hose 5m w/hand control.According to the complaint description, the hinge screw of the ga707r hand switch is damaged.The customer noticed that the screw had come off during this surgery.It seems that fragments of male screws remain inside the screws that have come off.The customer searched for it during surgery but could not find a half-split screw.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the lever was not on the coupling anymore upon receipt.Besides that, the device is in a used but good condition.The investigation has been carried-out by the aesculap technical service (ats).Normal signs of wear cold be found.Pressure and exhaust air tight according to specification.Lever is not on the coupling anymore.The next maintenance date would have been necessary in may 2021, complaint received: april 2021.Based on the provided information and after the investigation, a clear conclusion cannot be drawn.An internal change (no.61485) has been initiated and completed by the end of 2019 which included an adjustment of the used glue as well as an improvement of the assembly of the affected screw.This is the only complaint since that change.It is possible that an individual failure during the repair in may 2020 led to the loosening of the screw.There is no indication for a systematic failure based on the market surveillance.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 4(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 AIR MOTOR HOSE 5M W/HAND CONTROL
• 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: 11769752
• Report Number: 9610612-2021-00350
• Device Sequence Number: 4434071
• Product Code: HBB
• UDI-Device Identifier: 04046963835309
• UDI-Public: 4046963835309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA707R
• Device Catalogue Number: GA707R
• Device Lot Number: 52476603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown