MAUDE Adverse Event Report: COOPERSURGICAL, INC. IRC2100 W/ 210 LIGHTGUIDE

Model Number IRC-HS1

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Subject report number (b)(4).The reported condition was received by coopersurgical, inc.On june 30, 2019 via the united states postal service.An additional request dated july 10, 2019 was also received regarding the referenced report number the request was as follows: "we received the report(s) referenced above concerning on or more adverse events involving your device.To complete our evaluation of the event(s), we request the following information: we are unable to determine the fda premarket approval or clearance number for this device.Please provide the most recent fda premarket approval or clearance number for this device.Pma/510(k) number is k974168.Please confirm or provide the model, lot, serial, and/or catalog number(s) of the device listed in the medical device report as applicable.The model/catalogue number is irc-hs1 there was not lot/serial provided by user facility or end user.Please describe any design change(s) or modification(s) to the device, since the device was initially introduced to the market that may be related to the event.Please also include the date(s) the design change(s) or modification(s) occurred.No design changes that may be related to this report.It is unclear if this event was a result of the off-label use of this device.Please provide additional information to explain whether you believe this event represented an off-label use of the device.A review of the irc 2100 operating manual, page 7 care and cleaning section states: "the handpiece assembly console unit, and removable light guide must not be washed, soaked or rinsed." this guidance was derived from the disinfection validation based on dr.(b)(6) study and supersedes any guidance provided by disinfectant manufacturers." any further guidance should be directed to redfield corp.Please provide a copy (or electronic location) of all current labeling for the device, including directions for use, caution statements, technical manuals, and product performance reports.Once the investigation has been completed a follow up report will be filed.Reference (b)(4).

Event Description

Received under medwatch report # (b)(4).Description of event- device ifu conflicts with manufacturer's instructions and the best practices for disinfection.Concern for potential infection transmission in patients.Further statements: 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 www.Redfield.Com and is advertised for use in multiple healthcare settings.The irc 2100 is a device that comes into contact with mucous membrane (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, e.T.C, 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 the following this ifu, it directly conflicts with manufacturer ifus of disinfectants which work by soaking for certain amount of time, temperature, e.T.C.This appears to be a recognized problem, and dr.(b)(6) acknowledged this is in a study published in 2012 where he developed a different cleaning method fro this device.The redfield 2100 ifs are not consistent with the spaulding scale and are allegedly providing dr.(b)(6) instructions as an alternative method.If this method has indeed been validated, the company should update their ifu manual to reflect this.Report concluded - because we have no there option available, we are adopting the (b)(6) method/procedure in the interim.(b)(4).

• Brand Name: IRC2100 W/ 210 LIGHTGUIDE
• Type of Device: IRC2100 W/ 210 LIGHTGUIDE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8940668
• MDR Text Key: 156647542
• Report Number: 1216677-2019-08018
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IRC-HS1
• Device Catalogue Number: IRC-HS1
• Device Lot Number: NONE PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1