MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. ENDOSCOPE, UTEROSCOPE, VIPER

Model Number 7325.071

Device Problems Degraded (1153); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

Facility reported the flexible uteroscope went blurry during case; however, no injuries were reported.A slight delay in procedure was noted, in order to swap out to backup device.

Manufacturer Narrative

The actual device was returned to the richard wolf facility and investigation completed (b)(4) 2014.Upon visual and functional inspection by the optics department, the adhesive around the distal hose was missing.The root cause is reprocessing.Adhesive was re-applied and tested prior to returned to customer.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Rwmic considers this matter closed; however, in the event additional information is received, we will provide the fda with follow-up information.

• Brand Name: ENDOSCOPE, UTEROSCOPE, VIPER
• Type of Device: UTEROSCOPE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3850793
• MDR Text Key: 4617380
• Report Number: 1418479-2014-00009
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/20/2014

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
• Device Operator: Health Professional
• Device Model Number: 7325.071
• Device Catalogue Number: 7325.071
• Device Lot Number: 606652
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1