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

Model Number CD-B620LA

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was not received for evaluation.The user facility conveyed that they did not have the unit to return.No further details were provided.If additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system, and process changes.A capa has been opened to manage the actions related to remediation of this issue, and any required reporting.

Event Description

It was reported that the device did not heat up.The reported issue occurred when the unit was used with bi-coagulation setting.The event occurred during set up, and preparation for use.The user facility biomedical engineer confirmed that the other probes are functional, and with no issues.There was no patient involvement on this report.No user harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the trend analysis review and investigation conclusion.The device was discarded by the customer and not returned to olympus for evaluation.Therefore a definitive root cause could not be determined.Review of dhr or manufacturing procedures could not be completed as the lot number is unknown.Olympus will continue to monitor complaints for this device.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Type of Device: 7FR COAX HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10723110
• MDR Text Key: 213063561
• Report Number: 3011050570-2020-00121
• Device Sequence Number: 1
• Product Code: KNS
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CD-B620LA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1