MAUDE Adverse Event Report: CONMED UTICA FRAZIER; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0033100
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During incoming inspection, the distributor rejected this device, 0033100, surgical suction instrument, 10fr w/control vent & obturator, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received 40 of item 0033100 in unopened original packaging.Performed a visual inspection of the device, there were signs of a potential breach.10 of the devices had visible breaches where the item had poked through the heat seal.Performed a functional inspection; the devices were dye leak tested which indicated that the packaging of 6 more devices had insufficient heat seal on the packages and caused a leakage.However, the remaining 24 packages had no leakage at all.Root cause cannot be determined, however, based upon evaluation of the device and ifu; a possible cause of this event could be that the packages were improperly sealed.A two-year lot history review shows a total of 16 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 34 reports, regarding 114 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 per regulatory requirements to help ensure patient safety.

• Brand Name: FRAZIER
• Common Device Name: 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: 20852342
• Report Number: 1320894-2024-00416
• Device Sequence Number: 8040090
• Product Code: GCX
• UDI-Device Identifier: 30653405000123
• UDI-Public: (01)30653405000123(17)271211(10)202212121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 0033100
• Device Lot Number: 202212121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic