MAUDE Adverse Event Report: RICHARD WOLF GMBH URETERORENOSCOPE

Model Number	8708.517
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this case open.A follow up report will be submitted upon receipt of new or additional information.The user facility and manufacturer will be contacted to obtain additional information.
Event or Problem Description
On (b)(6) 2019, richard wolf medical instruments corporation (rwmic) received voluntary event report # mw5087618.It was reported that the 4 french port on the wolf semi ridged scope was occluded by debris causing the tip of the 0 top basket to shear off in the patient.Foreign body retrieval by doctor was successful.Patient was not harmed.User facility feels the device was not properly cleaned and handled down in prep and sterile.
Event or Problem Description
The purpose of this submission is to share additional information received from the user facility.
Additional Manufacturer Narrative
This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: additional information received from the user facility see section a.Also serial number received.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: URETERORENOSCOPE
• Common Device Name: URETERORENOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8881273
• Report Number: 1418479-2019-00033
• Device Sequence Number: 16695960
• Product Code: FGB
• UDI-Device Identifier: 04055207063323
• UDI-Public: 04055207063323
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022
• Report Date (Section F): 08/09/2019

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: Health Professional
• Device Model Number: 8708.517
• Device Catalogue Number: 8708.517
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 08/09/2019