MAUDE Adverse Event Report: RICHARD WOLF GMBH; FIBER-CYSTOSCOPE 15FR WL 400MM

Model Number	7305001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A medical supplier and richard wolf gmbh (rwgmbh) has been informed of an issue regarding an fiber-cystoscope 15fr wl 400mm, part id: 7305.001, sn# (b)(6).According to the received information, the general hospital of nikaia in athens reported three serious incidents with patients developing a severe hypoxemia, 10-15 minutes following cystoscopy.One of the patient had to be transferred to the intensive care unit.These happened on (b)(6) jan, (b)(6) feb, and (b)(6) 2024 respectively.The cases were started after the use of the instrument.All patients are now doing well.
Additional Manufacturer Narrative
The medical supplier sold the fiber-cystoscope 15fr wl 400mm, 7305.001, to the general hospital of nikaia in athens in january 2024 and was used for 25 cases after the reported incident happened.Rwgmbh has been provided information via the incident questionnaire that the defect did not occurred during the use of the device.Added, no risk to patient, users or third parties.Also, information regarding reprocessing, that listed two chemicals that have not been tested and/or approved by rwgmbh.Rwgmbh has requested the return of the product for further investigation.

• Common Device Name: FIBER-CYSTOSCOPE 15FR WL 400MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18935553
• Report Number: 9611102-2024-00012
• Device Sequence Number: 15214595
• Product Code: FAJ
• UDI-Device Identifier: 04055207013656
• UDI-Public: 04055207013656
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K980401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7305001
• Device Catalogue Number: 7305.001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown