MAUDE Adverse Event Report: RICHARD WOLF GMBH (GERMANY) FLEXIBLE FIBER-URETHRO-CYSTOSCOPE

Model Number	7305.001
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned as of 02/07/2017.An rma number was issued to the customer and the investigation will follow.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
A piece of the scope fell off and into the patient during a procedure.Rwmic contact the facility, a summary of the event is as follows: the scope came down from the procedure tagged by the surgeon, dr.(b)(6), noting that a piece fell off from the scope during the procedure and was retrieved from the patient with use of a rigid scope.No patient injury.Some delay in the procedure in order to retrieve the scope piece.
Event or Problem Description
Follow up #1.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation (rwmic) is the importer of device, not the manufacturer (initial report).Device not returned for evaluation/investigation.Facility suspects foreign object that fell off scope is a piece of epoxy due to the shape of object matching the missing epoxy on the device.Mfr date - 07oct2014 date sold - 06sep2015 service dates - 15mar2016 & 05jan2017 facility was contacted several times, via email and phone, in an effort gather additional/missing information as well as request the return of device.No response as of 03jan2018.Rwmic considers this matter closed.However, in the event rwmic receives any additional information a follow up report will be submitted to fda.

• Brand Name: FLEXIBLE FIBER-URETHRO-CYSTOSCOPE
• Common Device Name: URETHRO-CYSTOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH (GERMANY); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6308281
• Report Number: 1418479-2017-00002
• Device Sequence Number: 1407828
• Product Code: FBO
• UDI-Device Identifier: 04055207013656
• UDI-Public: 04055207013656
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K980401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017
• Report Date (Section F): 01/04/2018

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: Other
• Device Model Number: 7305.001
• Device Catalogue Number: 7305.001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/04/2018