MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; URETERORENOSCOPE 5° 6/7.5FR WL 330MM

Model Number 8702.517

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503)

Event Date 05/06/2022

Event Type  Injury  

Event Description

It was reported to richard wolf that "when scope and basket were being removed from the patient, part of the ureter was removed too.Will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? no.Did the delay put the patient at risk? unknown.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.Additional details about the adverse event: what is the current status of the patient? patient is being followed up at u of m.Was the ureter repaired? no, ureter was not repaired.It was dissected in two places.Patient currently has a nephrotube and is waiting for follow up at u of m.What kind of procedure was it? ureteroscopy, stone removal with laser and basketing.Was there any problem at the beginning of the procedure when they led the scope into the ureter? no.Was it already tight? as the dr was inserting the scope it went in with no problems.She noticed a slight stricture, stopped, pulled the scope back to assess the ureter.When it looked safe she proceeded with the procedure of scoping the ureter and then lasered the stone.Was there any visible damage on the scope which could cause the reported issue? scope appeared normal at the start of the case.Was there a stone in the basket? unsure.After lasering the stone, the first thing retrieved from the ureter was a blood clot.If yes, what was the size of the stone? would be in dr.Brownell's initial report.What kind of basket did they use: with tip or tip-less? zero tip basket.

Manufacturer Narrative

Richard wolf considers this mdr open.Rw will submit a follow up report after the device evaluation has been completed and/or new information (additional questions sent to the hospital) becomes available.

Event Description

Rwmic complaint reference (b)(4).The purpose of this submission is to close this mdr.See h10.Rwmic mdr awareness date: 12-may-2022.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #2 is to provide fda with new information about this mdr.The user facility was contacted several times in an effort to collect patient information and user information.The sales representative and particular individuals were contacted and asked to respond to rwmic questionnaire and issue related questions.However, as of 10-aug-2022, rwmic has not received a response.Dates of customer contact: 1st contact: (b)(6) 2022 via email, 2nd contact:(b)(6) 2022 via email & phone, 3rd contact:(b)(6) 2022 via email.In the associated ifu, ga-d 352 / usa / 2012-11 v4.0 / eco: 2012-0540, the user is informed about the following safety notice: section 7.4.2 - notes and instructions on electrohydraulic lithotripsy (ehl) ehl probes can be used for the fragmentation of ureter stones.This requires a continuous flow of irrigation water and direct contact between the probe tip and the stone as well as clear view of the concretion.Caution! danger of injuring the mucous membrane! direct contact with the mucous membrane while the ehl probe is activated can lead to perforations and / or hematomas.Guide the ehl probe under endoscopic view to the concretion and activate only after the probe tip is free and makes contact with the stone.When triggering electro-hydraulic shock waves, the probe tip must be at least 10 mm away from unprotected tissue.In the case of small distances make sure that the tissue is shielded by a concretion.This is essential for effective stone disintegration.Section 13 - warranty and customer service "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, partsmust 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." "delivery by richard wolf of technical documents such as circuit or other design diagrams does not constitute authorization for product repair or part replacement.Richard wolf instruments and other products should never be modified or altered under any circumstances.Contact richard wolf if you have any question (1) whether replacement of a part or a repair is authorized by richard wolf, or (2) whether you have complete instructions and specifications for part replacement or repair." therefore, richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report if new information becomes available.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new information about this mdr.According to the investigation report: only the scope was returned to richard wolf, the scope was evaluated and found no defects that would have caused or contributed to the reported issue.Additional findings: the scope has a blurry image, low light.There is evidence that it was repaired by a third party and has non wolf parts (photos on file at rwmic).The additional defects would not have contributed to the reported issue.Rwmic has recommended to repair the scope by removing the 3rd party parts and replace them using only richard wolf parts.Richard wolf medical instruments (rwmic) is submitting this mdr behalf of the device manufacturer, rw gmbh.Richard wolf medical instruments corporation (rwmic) considers this mdr open.Rwmic will submit a follow up report if new information becomes available.

Event Description

Rwmic complaint reference (b)(4).The purpose of this submission is to report the results of the device investigation.See h10.

• Brand Name: E-LINE
• Type of Device: URETERORENOSCOPE 5° 6/7.5FR WL 330MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 14552095
• MDR Text Key: 293447034
• Report Number: 9611102-2022-00023
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207063309
• UDI-Public: 04055207063309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8702.517
• Device Catalogue Number: 8702.517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/09/2022; 06/09/2022
• Supplement Dates FDA Received: 07/06/2022; 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability