MAUDE Adverse Event Report: RICHARD WOLF GMBH URETEROSCOPES

Model Number 7356071

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Rwmic has requested additional information from the user facility and the manufacturer for missing information; device evaluation results are expected and rwmic will provide a follow up report upon receipt of such information as appropriate.Rwmic considers this case open.

Event Description

Richard wolf medical instruments corporation, hereinafter referred to as rwmic was notified of an event that occurred at the hospital, on an unspecified date, during a patient procedure.The picture allegedly froze up while scope was in the ureter.A back up device was available and the procedure was completed.There was a delay in therapy that put the patient at risk but there was no adverse outcome reported as a consequence of this event.

Event Description

Follow up #2 to report new information to fda.

Manufacturer Narrative

Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.

Manufacturer Narrative

Follow up report #1 is to provide fda with missing, new, and changed information.Missing information: -the user facility was contacted in an effort to collect additional information, but no additional information could be provided.New information: changed information: the following fields have changed information: f3-5, h3.Device labeling was reviewed for patient and device codes, see below: patient code: not applicable, no patient problem was reported.Caution! caution if video signal processing fails! this may result in a delayed operation or a stop of the operation.There must always be an operable comparable device or a conventional system so that the user can complete the operation if the video image or led illumination fails.Important! do not pull at the supply cable! do not squeeze, compress and/or excessively bend the supply cable as this may cause damage to the wiring, leading to image and/or illumination failure.Caution! increased risk potential if the image is blurred! danger of injuring the patient.Stop the intervention for safety reasons if the image is blurred.Before use, check the image quality of the urs.Caution! do not work outside the scope's field of view! inadvertent tissue damage as well as damage to the distal end of the urs and to instrument parts is possible.Activate the laser only after -the tip of the laser fiber is fully visible through the urs and the pilot beam touches the area to be treated.Rwmic will follow-up with the manufacturer to obtain additional and missing information.A follow up report will be submitted upon receipt of new or additional information.Rwmic considers this case open.

Event Description

User facility returned the device to richard wolf medical instruments corporation (rwmic) on (b)(6) 2018, and the evaluation was completed on (b)(6) 2018.The device appeared to be slightly used.The device was evaluated by functional testing using camera setup, but no problems were found.The scope passed all tests and met specification and no manufacturing defects were identified.The device went through routine maintenance.

• Brand Name: URETEROSCOPES
• Type of Device: URETEROSCOPES
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7866793
• MDR Text Key: 120708482
• Report Number: 1418479-2018-00015
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207054864
• UDI-Public: 04055207054864
• Combination Product (y/n): N
• PMA/PMN Number: K990050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019,08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7356071
• Device Catalogue Number: 7356071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Distributor Facility Aware Date: 10/31/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other