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 Date 09/15/2023

Event Type  malfunction  

Event Description

This complaint was created due to the receipt of a notice from health canada of a vigilance report reference number 1066827 received on 18oct23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The reported device was the 0038730, yankar std bulb tip on/off ctrl w/o vent.The device was being used on (b)(6) 2023 and ¿surgery being performed on patient.Doctor using yankauer suction.The yankauer suction snapped in half where the control button" is.Both pieces of the single use sterile yankauer were removed from sterile field and replaced with a new yankauer.¿.Per further assessment the fragment did fall into the surgical site and was retrieved.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

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

This complaint was created due to the receipt of a notice from health canada of a vigilance report reference number (b)(4) received on 18oct23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The reported device was the 0038730, yankar std bulb tip on/off ctrl w/o vent.The device was being used on (b)(6) 2023 and ¿surgery being performed on patient.Doctor using yankauer suction.The yankauer suction snapped in half where the control button" is.Both pieces of the single use sterile yankauer were removed from sterile field and replaced with a new yankauer.¿.Per further assessment the fragment did fall into the surgical site and was retrieved.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review shows a total of eighteen (18) devices for this lot number and failure mode.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 review of complaint history revealed there has been a total of 15 reports, 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.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18011873
• MDR Text Key: 326620483
• Report Number: 1320894-2023-00237
• Device Sequence Number: 1
• Product Code: GCX
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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?: No
• Date Manufacturer Received: 11/16/2023
• 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