MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; SHEATH RESECTOSCOPE 24 FR

Model Number	8676424
Medical Device Problem Codes	Material Fragmentation (1261); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rw mic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rw (b)(4) considers this mdr/complaint open.Rw (b)(4) will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
The distal end of the sheath resectoscope 24fr was broken during use.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation and follow-up communication with the user facility.
Additional Manufacturer Narrative
The user facility has informed rw gmbh on (b)(6), 2021 [translated directly from german]: "the users report that the defect device 8676.424, batch #1327402 came from the central sterilization with marking "defect".The defect on the device was noticed in the reprocessing department after machine cleaning.The users are not aware of a defect during a procedure beforehand or any patient hazard." additional communication with the user facility: they discovered the defect after the sterilization.They have checked if there was any incident with the device beforehand during use, but no evidence was found.They think the tip broke during reprocessing, device evaluation: the root cause is ascribed to mechanical stress or fall.Due to the received information from the user facility and the result of the investigation, rw gmbh considers this matter as non-reportable incident and closed.However, in the event rw gmbh receives any additional information a follow up report will be submitted to fda.Rwmic is submitting report on behalf of rw gmbh.

• Brand Name: SHARK
• Common Device Name: SHEATH RESECTOSCOPE 24 FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12302373
• Report Number: 9611102-2021-00031
• Device Sequence Number: 14404736
• Product Code: FJL
• UDI-Device Identifier: 04055207019740
• UDI-Public: 04055207019740
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: No Information
• Device Model Number: 8676424
• Device Catalogue Number: 8676424
• Device Lot Number: 1327402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1