MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; CYSTOSCOPE 5° 9.5/11.5FR WL 116MM RIGID

Model Number 8626431

Device Problem Material Separation (1562)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4) considers this mdr open.(b)(4) will submit a follow up report after the device evaluation has been completed and/or new information (additional information from the user facility) becomes available.

Event Description

Richard wolf received a medwatch report from the fda.It was reported to: "physician was doing a cystoscopy on the patient with a richard wolf (b)(4) panoview cystoscope.Physician noticed a foreign body inside the bladder of the patient.Medical staff checked and the scope was missing its lens cover.The surgeon retrieved the lens cover by using a grasper.No harm to the patient.".

Event Description

The purpose of this submission is to report the results of the device investigation.The investigation: device was received and was visually and functionally evaluated.The reported condition - lens broke off device and fell into patient - was confirmed during evaluation.Findings: missing front lens, moisture in optic system.Housing damage by non-wolf repair.The scope was manufactured in 2013.Since then, it was never sent back to rwmic nor rw gmbh for maintenance or repairs.The investigation shows a pin inserted into the housing.This is a non-wolf modification and the purpose is unknown.Cause for missing lens cannot be determined due to the non-wolf maintenance and repairs.Product disposition: repair.Probable root cause: user error.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted in an attempt to collect patient and user information.Response received on 11/4/2021 that no additional information would be provided.New information: the following fields have new information: b5, h3, h6, h7, h8, h10.Changed information: the following fields have changed information: d8.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed: in section 12 warranty and customer service: all products should be returned to richard wolf for any necessary or desired repair or part replacement.No product repair or part replacement should be done other than by richard wolf unless the care and instruction manual or other written information indicates that repair or part replacement is authorized.If authorized, parts must be replaced only by parts supplied or specified by richard wolf, and product repair and part replacement must be done in strict conformance with richard wolf specifications and instructions for repair and part replacement, including post replacement testing and recalibration.Failure to fol-low this requirement in any way can be dangerous to you, your personnel and your patients and voids the warranty for the product repaired or the product in which the part was replaced and if the part was supplied by richard wolf, for that part.Delivery by richard wolf of technical documents such as circuit or other design diagrams does not consti-tute authorization for product repair or part replacement.Richard wolf instruments and other products should never be modified or altered under any circumstances.Contact richard wolf if you have any question (1) whether replacement of a part or a repair is authorized by richard wolf, or (2) whether you have complete instructions and specifications for part replacement or repair.Repair policy: defective merchandise will be repaired or replaced at no charge to the customer, provided the customer delivers such defective merchandise prepaid.Any repairs, maintenance or servicing of richard wolf mer-chandise by anyone other than a factory authorized representative will render our warranty null and void.Rwmic considers this mdr closed.Rwmic will submit a follow up report should we receive new information.

• Brand Name: PANOVIEW
• Type of Device: CYSTOSCOPE 5° 9.5/11.5FR WL 116MM RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12656545
• MDR Text Key: 281605843
• Report Number: 1418479-2021-00047
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04055207018064
• UDI-Public: 04055207018064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 8626431
• Device Catalogue Number: 8626.431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1