MAUDE Adverse Event Report: CONMED UTICA FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	0033080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The sales representative reported on behalf of the customer that the device, (b)(4), frazr suctn instr c/w contrl vent & obtu was being used on approximately (b)(6) 2022 and "the item broken during the surgery¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.After further assessment it was found that ¿during the surgery the cannula broke into the patient nose.The grip remained to the surgeon and the cannula in the patient nose and after it fall down.¿ the fragments were retrieved.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 0033080, frazr suctn instr c/w contrl vent & obtu was being used on approximately (b)(6) 2022 and "the item broken during the surgery¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.After further assessment it was found that ¿during the surgery the cannula broke into the patient nose.The grip remained to the surgeon and the cannula in the "patient" nose and after it fall down.¿ the fragments were retrieved.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Performed a visual inspection, both devices came back with the shafts broken.Performed a functional inspection, the devices are extremely fragile and flexible.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.(b)(4).Per the instructions for use, the user is advised the following: this suction device is indicated for use only by persons trained in suctioning procedures.This instrument is indicated for use in procedures where fine, delicate suctioning is required versus the general suctioning indicated in larger open procedures where the yankauer or poole is used.Aluminum or steel shaft is malleable, which, with obturator in place, can be easily shaped and contoured to meet a variety of clinical applications.Once shaft is shaped to clinician¿s preference, obturator must be removed before suctioning.Open thumb vent allows the clinician to better control suctioning by varying the rate or pressure of suctioning.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU
• 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: 15083647
• Report Number: 1320894-2022-00161
• Device Sequence Number: 20124013
• Product Code: GCX
• UDI-Device Identifier: 30653405000116
• UDI-Public: (01)30653405000116(17)261003(10)202110041
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: Health Professional
• Device Expiration Date: 10/03/2026
• Device Model Number: 0033080
• Device Catalogue Number: 0033080
• Device Lot Number: 202110041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic