MAUDE Adverse Event Report: RICHARD WOLF GMBH INNER SHEATH RESECTOSCOPE

Model Number 86770155

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Rwmic will also gather information from the manufacturer and will attempt to gather additional information from the user facility.A follow up report will be submitted when such information becomes available as appropriate.

Event Description

Richard wolf medical instruments corporation, hereinafter referred to as rwmic was notified of an event that occurred during patient use at the user facility.Date of occurrence was not specified.The customer reported that shavings from the inner sheath of the ceramic tip flaked off inside a patient's bladder.The pieces were removed from the patient and there was no adverse outcome to the patient.

Manufacturer Narrative

Follow up #2 is to provide fda with new information.Rwmic considers this case closed.Should additional information become available a follow up report will be submitted.

Event Description

Fu #2 to provide new information.

Event Description

User facility returned the device to richard wolf medical instruments corporation (rwmic) on september 06, 2018, and the evaluation was completed on october 01, 2018.The device appeared to be used and broken - ceramic tip is out.The reported condition was verified using visual testing.It is suspected that the device had been previously worked on by a third party, which may have led the tip to break.The ceramic tip and was replaced and cleaned.

Manufacturer Narrative

Follow-up report#1 is to provide fda with new and changed information: new information: device labeling was reviewed for patient code and device codes, see below: device code: ifu was reviewed, see below: all products should be returned to richard wolf for any necessary or desired repair or part replacement.No product repair or part replacement should be done other than by richard wolf unless the care and instruction manual or other written information indicates that repair or part replacement is authorized.If authorized, parts must be replaced only by parts supplied or specified by richard wolf,and product repair and part replacement must be done in strict conformance with richard wolf specifications and instructions for repair and part replacement, including post replacement testing and recalibration.Failure to follow this requirement in any way can be dangerous to you, your personnel and your patients and voids the warranty for the product repaired or the product in which the part was replaced and if the part was supplied by richard wolf, for that part.Attempts were made to collect additional/missing information from the user facility, but no additional information could be provided.Additional attempts will be made to collect device information from the manufacturer.Rwmic considers this matter open.Follow-up reports will be submitted as required.

• Brand Name: INNER SHEATH RESECTOSCOPE
• Type of Device: INNER SHEATH RESECTOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7855453
• MDR Text Key: 119660747
• Report Number: 1418479-2018-00018
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028230
• UDI-Public: 04055207028230
• Combination Product (y/n): N
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018,08/24/2018

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
• Device Operator: No Information
• Device Model Number: 86770155
• Device Catalogue Number: 86770155
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2018
• Distributor Facility Aware Date: 11/06/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/01/2018; 10/01/2018
• Supplement Dates FDA Received: 11/01/2018; 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other