MAUDE Adverse Event Report: CONMED CORPORATION CARDIAC YANKAUER CLEAR SINGLE USE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 0034470

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the 0034470 was being used during a cardiac surgery on (b)(6) 2021 when it was reported that the suction tip fell into patient and was retrieved.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the tip component had fallen into the patient and was retrieved with a forceps.This caused a 3-5-minute delay for retrieval and to use an alternate device to complete the procedure.The patient status was listed as "recovery".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device was not returned for evaluation to date and no photographic evidence was provided.When the device is returned, an evaluation will be performed, and the event file will be updated.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame 12,250 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00008.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CARDIAC YANKAUER CLEAR SINGLE USE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 11982667
• MDR Text Key: 255641852
• Report Number: 1320894-2021-00292
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0034470
• Device Lot Number: 202010121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 103