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

Catalog Number IFS-VALVE1

Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250); Pressure Problem (3012)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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 Description

The sales representative reported on behalf of the customer that the ifs-valve1 device was in storage on (b)(6) 2021 when it was reported that "while the device was stored in an equipment room it was discovered that a sound was coming from the pressure gauge on the co2 manifold.It suddenly blew the top of the gauge off.Because the fluid inside started leaking out the switch was turned to relieve the pressure on that side of the manifold at which point the other gauge did the same thing." upon further assessment, it was discovered that the "top of the gauge blew off with a loud bang and hit the ceiling on both gauges." it was assumed the fluid leaking was lubricant for the dial inside the gauge.There were no injuries reported.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event of "fluid in the gage began leaking out and the top of the gauge blew off" is confirmed.A dhr review could not be conducted as a serial number was not provided.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.

• 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
• MDR Report Key: 11461073
• MDR Text Key: 241059677
• Report Number: 1320894-2021-00107
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: IFS-VALVE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1