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

Model Number 7305001

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2023

Event Type  Injury  

Manufacturer Narrative

The fiber cystoscope 15 ch iml 400mm, part id: 7305.001, with the serial number (b)(6), was produced on 30/aug/2019 under order number (b)(4).The order size was (b)(4) pieces.There were no anomalies during production and the entire batch successfully passed the final inspection.The fiber cystoscope 15 ch iml 400mm was delivered to the customer on 28/nov/2019.On 07/aug/2023 instrument was in house for repair.The unwinding was repaired and the instrument was sent back to the customer on 05/oct/2023.The current complaint (b)(4) refers to cloudy vision, here the fault can be attributed to insufficient cleaning.The repair with the repaired processing can be excluded as a subsequent fault.A query on comparable complaints has revealed that there have only been 2 comparable cases in the last 3 years.Also, no other serial numbers from production order (b)(4) were complained about.At the same time, (b)(4) units were sold worldwide in the same period.A general product problem can therefore be ruled out.The fiber cystoscope was examined by the specialist department and it was found that the glass plates on the outside of the eyepiece were fogged up.This defect is seen in connection with inadequate reprocessing.In the corresponding instructions for use ga-j050/2014-05 v7.0/pdi 13-6891 and ga-s006 /en/2019-05 v14.0 / pk18-9407, reference is made to visual and functional checks in chapter 7 "inspection and maintenance" (ga-j050) and chapter 9 "checks" (ga-s006).Possible hazards have been identified in risk assessment a3: "reusable flexible optics", document number 10000309115 ver.00, under chemical hazards: anesthetic agents, under ageing damage due to reprocessing or use as acceptable and taken into account with the corresponding extent of damage and probability of occurrence.In summary, we can say that this batch has no general product problem.The associated instructions for use refer to the service life and correct reprocessing and inspection of the products.The defect can be traced back to cleaning/care errors.This error can be easely detected prior use.

Event Description

A user has informed richard wolf gmbh (rwgmbh) of an issue regarding an fiber-cystoscope 15fr wl 400mm, part id: 7305.001, sn# (b)(6).According to the received information, during the patient's treatment, vision became increasingly poor as water/condensation on the lens caused it to fog up.Later, the user stated that the treatment had to be discontinued due to this.There is no report of injury to the patient or other personnel.

• Type of Device: 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: 18836687
• MDR Text Key: 336890122
• Report Number: 9611102-2024-00010
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04055207013656
• UDI-Public: 04055207013656
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K980401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7305001
• Device Catalogue Number: 7305.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other