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

Model Number CD-B622LA

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2020

Event Type  malfunction  

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 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.

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
• Type of Device: 7FR FIXEDPIN HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11154851
• MDR Text Key: 250463075
• Report Number: 3011050570-2021-00011
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• Combination Product (y/n): N
• PMA/PMN Number: K123319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-B622LA
• Device Lot Number: KR914615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1