MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR FIXEDPIN HEMOSTATIC PROBE

Model Number	CD-B622LA
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported event cannot be determined.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that the device was found not working, the probe failed to work.There was no patient involvement reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The subject device was disposed by the customer, therefore was not available for physical evaluation.The device history record was reviewed and showed the product met all specifications upon release.As the device was not returned for physical/functionality evaluation, the root cause could not be conclusively determined.Based on the (instruction for use ) ifu, user should only use the probe with the identified compatible devices listed in the ifu.Use this device only with appropriate products identified in the table below.If the device is used with products outside of these specifications, patient or operator injury, malfunction or equipment damage may occur.Do not connect components not specified in the instructions for use.Refer to the generator user manual for instructions regarding assembly and initial system check.Olympus will continue to monitor complaints for this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11154851
• Report Number: 3011050570-2021-00011
• Device Sequence Number: 4132504
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: CD-B622LA
• Device Lot Number: KR914615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1