MAUDE Adverse Event Report: COOPERSURGICAL, INC. REDFIELD IRC 2100 INFRARED COAGULATOR; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number IRC-HS1

Device Problems Device Reprocessing Problem (1091); Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

Device ifu conflicts with manufacturer's instructions and best practices for disinfection.Concern for potential infection transmission in patients.A physician who practices at our healthcare facility has indicated he/she will begin to use the irc 2100 coagulator manufactured by redfield corporation.The manufacturer's website is (b)(6) and is advertised for use in multiple healthcare settings.The irc 2100 is a device that comes into contact with mucous membranes (anus) and would be considered a semi-critical instrument, requiring high level disinfection (hld).The product's instructions for use (ifu) state a number of disinfectants are acceptable to use such as cidex, methracide, etc.All of these are high level disinfectants.However, the ifu further states that the device cannot be washed, soaked or rinsed, and directs the users to wipe clean with the hlds above.In following this ifu, it directly conflicts with manufacturer ifus of disinfectants which work by soaking for a certain amount of time, temperature, etc.This appears to be a recognized problem, and doctor (b)(6) acknowledged this in a study he published in 2012 where he developed a different cleaning method for this device.The redfield 2100 ifus are not consistent with the spaulding scale and are allegedly providing doctor (b)(6) instructions as an alternative method.If this method has indeed been validated, the company should update their ifu manual to reflect this.Because we have no other option available, we are adopting the (b)(6) method/procedure in the interim.

• Brand Name: REDFIELD IRC 2100 INFRARED COAGULATOR
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8726664
• MDR Text Key: 148946757
• Report Number: 8726664
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IRC-HS1
• Device Catalogue Number: IRC 2100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1