MAUDE Adverse Event Report: CONMED UTICA YANKAR STD BULB TIP ON/OFF CTRL W/O VENT; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 0038730

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 0038730, yankar std bulb tip on/off ctrl w/o vent, was being used during an unknown procedure on an unknown date when it was reported ¿yankauer was being used by doctor- broke in half.Nurse in the room (not the nurse reporting this complaint) stated it happened 2 other times this week in a different case.All pieces look to be recovered.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.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.A two-year lot history review shows a total of (b)(4) devices for this lot number and failure mode, however none are confirmed.A two-year review of complaint history revealed there has been a total of 14 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4) we will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 0038730, yankar std bulb tip on/off ctrl w/o vent, was being used during an unknown procedure on an unknown date when it was reported ¿yankauer was being used by doctor- broke in half.Nurse in the room (not the nurse reporting this complaint) stated it happened 2 other times this week in a different case.All pieces look to be recovered.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: YANKAR STD BULB TIP ON/OFF CTRL W/O VENT
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17942259
• MDR Text Key: 325758798
• Report Number: 1320894-2023-00213
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10653405000631
• UDI-Public: (01)10653405000631(17)280311(10)202303131
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0038730
• Device Lot Number: 202303131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic