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

Model Number 8702.517

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information (user faciility has been contacted with additional questions) becomes available.

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 (b)(6).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 (b)(6).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.(b)(6) initial report.What kind of basket did they use: with tip or tip-less? zero tip basket.

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 corporation (rwmic) considers this mdr open.Rwmic will submit a follow up report if new information becomes available.

Event Description

The purpose of this submission is to report the results of the device investigation.See h10.

Manufacturer Narrative

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: 5/27/2022 via email.2nd contact: 6/8/2022 via email & phone.3rd contact: 7/7/2022 via email.Therefore, richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report if new information becomes available.

Event Description

Rwmic complaint reference no.: (b)(4).The purpose of this submission is to close this mdr.Rwmic mdr awareness date: 12-may-2022.

• 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
• MDR Report Key: 14552168
• MDR Text Key: 293277181
• Report Number: 1418479-2022-00015
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207063309
• UDI-Public: 04055207063309
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2022
• Distributor Facility Aware Date: 05/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/06/2022; 08/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability