MAUDE Adverse Event Report: CONMED CORPORATION VALVE W/HOSES & MTG BRACKET; TUBING, PRESSURE AND ACCESSORIES

Catalog Number IFS-VALVE1

Device Problem Unintended Ejection (1234)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Received one ifs-valve1 opened in unoriginal packaging.The lot number of the device was not confirmed.A visual inspection found oily liquid on the device and no other defects or abnormalities.A functional inspection was performed by connecting the ifs-valve1 to air seal ifs system (c8457) and co2 tank.Hose (p/n: ab30749) was connected to the right side of the switching valve and co2 was increased and air seal system turned on for use as intended.Hose (p/n: ab30749) was then switched to left side of switching valve and co2 was increased and the rubber stopper at the top of the dial on the utility gage (p/n: p000004626) flew off.Liquid from inside the dial leaked out.A device history record review could not be conducted as a serial number was not provided.The service history could not be reviewed as a serial number was not provided.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 1,518 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 0.002.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the ifs-valve1 device was used during a non-surgical event when it was reported "when the gas was turned on, the stopper flew out hitting the rep." there was no report of injury, medical intervention, or hospitalization for the conmed sales representative.The representative did not sustain any injury; however, it was discovered that the component hit the representative in the face near the eye.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: VALVE W/HOSES & MTG BRACKET
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 11831427
• MDR Text Key: 250838588
• Report Number: 1320894-2021-00220
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: IFS-VALVE1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1