MAUDE Adverse Event Report: CONMED UTICA OPEN TIP YANKAUER W/VENT (50/CS); APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 0034980

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation of the customer's complaint of an insufficient heat seal leading to a breach in sterility has confirmed the reported issue.Conmed received three 0034980 returned unopened in original packaging.The lot number of the devices ¿ 202006151 was verified via returned packaging.A visual inspection found an open hole in the packaging of one device.The seal on the packaging of the second device was slanted leaving a gap with a hole in the unsealed portion and the third has folds in the seal with small open holes.A functional inspection and dye leak testing were not necessary as the breaches in sterility were obvious.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review shows a total of two (2) complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 6 complaints, regarding 8 devices, for this device family and failure mode.During this same time frame 7,035,300 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 0.000001.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

During incoming inspection, the distributor rejected this device, catalog # 0034980, lot 202006151, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in japan.The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: OPEN TIP YANKAUER W/VENT (50/CS)
• 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: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12758892
• MDR Text Key: 281338376
• Report Number: 1320894-2021-00404
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10653405000341
• UDI-Public: (01)10653405000341(17)250614(10)202006151
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0034980
• Device Catalogue Number: 0034980
• Device Lot Number: 202006151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic