MAUDE Adverse Event Report: UNKNOWNGYRUS ACMI INC SHOCKPULSE PROBE; UNKNOWN

Model Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The probe was returned stuck inside the transducer.Upon receipt the probe was observed to be damaged.The model and lot number of the probe were not recorded.Therefore, there is no record of an evaluation being performed.At the customer¿s request, the device was returned to the customer unrepaired.An investigation is ongoing to obtain additional information regarding this event.
Event or Problem Description
The service center was informed during preparation for use, there was a problem with the probe.There was no report of patient involvement.
Additional Manufacturer Narrative
Upon further review by the legal manufacture at the time of device evaluation, it was observed that the device is not manufactured by olympus and does not need to be reported by olympus.The manufacturer of the device could not be determined from the device part that was returned.No information was received from the customer when due diligence was executed.Please see the updates in sections: g3, g6, h2, and h10.

• Brand Name: SHOCKPULSE PROBE
• Common Device Name: UNKNOWN
• Manufacturer (Section D): UNKNOWNGYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11247405
• Report Number: 3011050570-2021-00034
• Device Sequence Number: 3583576
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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 Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1