MAUDE Adverse Event Report: COGENTIX MEDICAL INC ENDOSHEATH CF-2.1 PROTECTIVE BARRIER; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number CF 2.1

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

Cystoscope was removed from the sheath and wetness was seen on the scope.This is an indication that there was a breach in the sheath somewhere.Scope was flagged and sent to reprocessing to be sterilized.No harm was caused to the patient as the scope itself had been reprocessed with low-level disinfectant between patients and sterilized prior to being put in use.Manufacturer response for cognetix cystoscope sheath, (brand not provided) (per site reporter): unknown.

• Brand Name: ENDOSHEATH CF-2.1 PROTECTIVE BARRIER
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): COGENTIX MEDICAL INC; 135 flanders rd; westborough, MA 01581
• MDR Report Key: 5846292
• MDR Text Key: 51161577
• Report Number: 5846292
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2016

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: CF 2.1
• Device Catalogue Number: 08-4101
• Device Lot Number: L1051816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2016
• Device Age: 1 DY
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 77 YR