MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. CYSTOSCOPE, FLEXIBLE, 15 FR

Model Number 7305.006

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed as the actual device was returned to the (b)(4) facility on 07/02/2015.The brushing that fell into the patient had laser damage completely through, splitting it.The busing was then able to be squeezed smaller than the working channel and fall out of the device (see attached photo).The objective head of device also took a strong laser hit and vertebrae was broken in two places.Above damage indicates user error during the handling of the device.Device was purchased new on (b)(6) 2014.Request for add'l info sent to initial reporter.No response as of 07/24/2015.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.(b)(4) considers this matter closed.However, in the event we receive add'l info, we will provide fda w/follow-up info.See scanned page.

Event Description

(b)(4) was notified by facility that during a procedure a piece of the device in question broke off into patient.Foreign object was easily retrievable and procedure completed as scheduled w/no injury to patient.

• Brand Name: CYSTOSCOPE, FLEXIBLE, 15 FR
• 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: 4953248
• MDR Text Key: 23023475
• Report Number: 1418479-2015-00022
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Not Applicable
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7305.006
• Device Catalogue Number: 7305.006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Unknown
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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