MAUDE Adverse Event Report: CYTOPHIL, INC. RENÚ GEL, 1.5CC; SYSTEM, VOCAL CORD MEDIALIZATION

Model Number	08-015-00-V04
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records did not reveal any irregularities or issues with syringe.Cytophil received the complaint device for evaluation.The device was evaluated "as received" under 50x magnification.It was then carefully rinsed and viewed again under 50x magnification.There was no visible defect viewed under magnification.The syringe was then filled with water as a worst case test, a closed stopcock was attached to the luer end, and the syringe was tested under pressure, with no leakage occurring.The device performed according to specification.In an attempt to recreate the reported event, cytophil then backed the stopcock off the luer connection, and was able to reproduce a minor drip/leakage at the hub/luer.This implies an issue with either the needle hub, or that the needle may not have been fully engaged or seated within the luer connection.Cytophil did not receive the needle for evaluation.However, as the user stated, the same needle was used with both the complaint device, and then with the second renu gel device, with no reported issues.With regard to the complainant's observation that there was moisture in the pouch, this is a normal event.The renu gel device is sterilized using steam and pressure, which requires that a small amount of water be injected inside the foil pouch prior to sterilization.The renu gel instructions for use explains that the moisture is an essential part of the sterilization cycle, that the residual moisture is a normal expected occurrence and is not an indication of a defective product.The results of cytophil's complaint investigation are inconclusive.Cytophil was unable to confirm the reported complaint, or to definitively identify a root cause of the reported event.A review of cytophil's complaint history for the past 24 months indicates one similar complaint.The complaint is being closed, and will be tracked.
Event or Problem Description
The ent surgery center reported that when they opened a renu gel device during a case, the device "seemed to be broken inside the aluminum package.When the nurse opened it onto the field, he noticed the inside of the package was wet and dripping." the physician then attempted to use the device but was unsuccessful in using the device.It was reported that the renu gel leaked out the sides where the syringe attached to the needle.There was a second renu gel device in the procedure room which was used to successfully complete the procedure.

• Brand Name: RENÚ GEL, 1.5CC
• Common Device Name: SYSTEM, VOCAL CORD MEDIALIZATION
• Manufacturer (Section D): CYTOPHIL, INC.; 2485 corporate circle; suite 2; east troy WI 53120
• MDR Report Key: 6952826
• Report Number: 3007225376-2017-00005
• Device Sequence Number: 891856
• Product Code: MIX
• UDI-Device Identifier: 00856509002935
• UDI-Public: (01)00856509002935(10)S708-00035(17)190621
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K150400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2017

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: Physician
• Device Expiration Date: 06/21/2019
• Device Model Number: 08-015-00-V04
• Device Lot Number: S708-00035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 67